Content analysis of drug recall announcements in Saudi Arabia: Between 2016 and 2022

Content analysis of drug recall announcements in Saudi Arabia: Between 2016 and 2022 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Content analysis of drug recall announcements in Saudi Arabia: Between 2016 and 2022 Malak Almutairi, Aljoharah Algabbani, Ajbaa Al Asiri, Ali Al Homaidan, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3137976/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose This study aims to analyze drug recall reports issued by the Saudi Food and Drug Authority (SFDA) in Saudi Arabia over seven years and describe the practice of pharmaceutical companies regarding voluntary drug recalls. Methods A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between July 2016 and December 2022. The study included registered and unregistered drug recalls posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on variables such as recall year, report language, number of report items, depth of recall, product name, therapeutic class, product registration status, recall type, pharmaceutical company type, recall reasons, and voluntary or involuntary product defect reports. Results During the study period, a total of 375 products were recalled, with the majority being involuntary recalls (82.7%). Over two-thirds of the recalls (66.4%) were related to registered products. The most common reasons for recalls were non-compliance with manufacturer's specifications (33.3%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recall of defective products. Innovator pharmaceutical companies tended to request voluntary recalls more often than generic pharmaceutical companies. Conclusion The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Innovator pharmaceutical companies were more likely to request voluntary recalls for product defects compared to generic pharmaceutical companies. Drug recalls Recalls announcement SFDA Pharmaceutical companies Figures Figure 1 Figure 2 Introduction Poor-quality medicines are a significant public health issue, mainly affecting developing countries and impacting their emerging market economies. The World Health Organization (WHO) reports that 1 in 10 substandard medicines is distributed in low- and middle-income countries countries[ 1 ]. The availability of falsified and substandard medicines, whether branded or generic, has become a major concern due to their potential impact on patient health. These substandard medicines can lead to treatment failure, adverse drug reactions, and antimicrobial resistance, resulting in serious health crises [ 2 ]. In fact, it has been estimated that over 116,000 deaths occur annually in sub-Saharan Africa due to substandard and falsified antimalarials, with economic losses exceeding US $ 40 million [ 3 ]. The widespread presence of substandard medicines can be attributed to inadequate regulation and governance by regulatory authorities, as well as unethical practices by wholesalers and healthcare practitioners [ 4 ].In response, drug regulatory authorities and pharmaceutical companies implement drug recalls as a means to mitigate the impact of substandard medications [ 4 ].Drug recalls involve the removal or withdrawal of defective drugs from the market and can be initiated either voluntarily by the company or involuntarily by the public, including healthcare professionals and consumers [ 5 ]. While the number of drug recalls has been increasing in recent years, with a focus on ensuring the safety and efficacy of drugs and medical products for consumers, there is limited research analyzing the patterns and characteristics of drug recall announcements issued by regulatory authorities [ 6 , 7 ].Previous studies have explored aspects such as patterns of recalls, distribution of recalls among pharmaceutical firms, and the most common reasons for recalls in specific regions like the United States (U.S) [ 8 ]. In Saudi Arabia, there has been a notable increase in drug recall trends, particularly in 2018, compared to the previous decade [ 9 ]. However, no studies have specifically investigated the patterns of drug recall requests by manufacturers or the public in the country. Therefore, there is a need for regulatory authorities to understand the drug recall process and the behavior of pharmaceutical companies to ensure the safety of products. The aim of this study is to analyze the content of drug recalls issued over a seven-year period by the Saudi Food and Drug Authority (SFDA) and examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects. Method A retrospective data analysis was conducted using drug recall announcements issued by the Saudi Food and Drug Authority (SFDA) between July 2016 and December 2022. Data were collected from the SFDA Drugs Circulars and Withdrawal webpage, which includes registered and unregistered drug recall announcements. The National Pharmacovigilance and Drug Safety Center (NPC) at SFDA provided access to the database for data extraction [ 7 , 8 , 10 ]. The study included all human drugs that were subject to recall. Two researchers extracted relevant information from the recall announcements, which included data such as recall action date, announcement number, announcement language, number of reported items, product name, therapeutic class, product registration status (registered or unregistered), type of recall, company name, issues identified, recall reasons, drug recall class (I, II, and III) [ 13 ], and whether the recall was voluntary or involuntary. Definitions of these groups are shown in (Table-1). Recall reasons were categorized into groups, including non-compliance with manufacturer's specifications, packaging defects, failure to demonstrate bioequivalence, contamination, chemical impurities, incorrect therapeutic dose, violations, and adverse reactions. The recalls were further classified based on the World Health Organization's Anatomical Therapeutic Chemical (ATC) Classification System [ 14 ]. Descriptive analysis was performed to calculate frequencies and percentages for various data categories, such as the number of drug products, number of recalls reported each year, recall type, product formulation, report classification, reasons for recall, complexity of recalls, registered and unregistered recalls, voluntary and involuntary recalls, therapeutic class, innovator pharmaceutical companies, and generic pharmaceutical companies. Statistical analysis was conducted using SPSS software (version 26.0). Results Between July 2016 and December 2022, a total number of 375 products were recalled and analyzed. The highest recall announcements were reported in 2019 [153, (40.8%)] compared to other years (Figuer-1). The majority of recalls were involuntary [310, (82.7%)], while [65 ,(17.3%)]of recalls were voluntary. The most voluntary recalls were reported in 2022 [17, (%53)] compared to the past six years (Table-2). In addition, two-thirds [249, (66.4%)] of recalls were related to registered products in the SFDA, unregistered products were accounted for the remaining recalls [126, (33.6%)]. In terms of the complexity of the reports, the majority of reports included one product [147, (77%)], while 23% (N: 44) reports included more than one product (Table − 2). The most common reasons for recalls were as follows: non-compliance with manufacturer's specifications [125, (33.3%)], contamination [89, (23.7%)], violations [77, (20.5%)] and chemical impurities [38, (10.1%)], more details are presented in (Table-3). Most of the recall’s types were identified as batch recall [284, (75.7%)], followed by product recall/ registration suspension [52, (13.9%)], and product recall [30, (8%)] (Table − 2). In terms of product formulations, the majority of recalls were tablets [186, (49.6%)] followed by injectable products [99, (26.4%)] (Table − 2). Forty-one therapeutic classes were found in the product recalled reports; of those, seven therapeutic classes were highlighted as the highest recall frequency throughout the study period (2016–2022) as shown in (Figure − 2). Antacid was reported as the highest-recalled therapeutic class in three different years (2017, 2019 and 2020). A total of 109 pharmaceutical companies were involved in the recall reports we reviewed. Of those, 14.7% (N: 16) companies were innovator pharmaceutical companies and 85.3% (N: 93) companies were generic pharmaceutical companies. About 68.8% (N:11) of innovator pharmaceutical companies requested voluntary drug recall of defective products whereas 16% (N: 15) of generic pharmaceutical companies requested voluntarily drug recall (Table-3). Discussion/Conclusion This study aimed to analyze the content of drug recall announcements issued by the SFDA in Saudi Arabia over seven years. The results shed light on the patterns of pharmaceutical companies in requesting voluntary or involuntary drug recalls for defective products and highlight the most frequent causes of drug recalls. During the study period, the highest number of product recalls was reported in 2019. Furthermore, the most frequently recalled therapeutic classes between 2016 and 2022 were antihypertensives and antacids. While these findings indicate an increase in drug recalls, there is insufficient evidence to explain the root cause of this trend. This study shared some similarities with AlQuadeib et al., which showed that the highest recall happened in 2018, and antihypertensives and antibiotics were the most recalled therapeutic classes in Saudi Arabia [ 9 ]. Product recalls have a negative impact on the reputation and economic status of companies, including stock prices and sales of affected products [ 15 ]. Interestingly, our results suggest that innovator companies are more likely to voluntarily request a drug recall when a product defect occurs compared to generic companies. The SFDA plays a vital role in ensuring the safety of pharmaceutical products and publishing warnings related to defective products [ 16 ]. In this study, the most common reasons for drug recalls were non-compliance with the manufacturer's specifications (33.3%) and contamination (23.7%). These findings align with previous studies conducted in the United States and Saudi Arabia, highlighting mislabelling and contamination as significant causes of drug recall. Notably, a considerable proportion (33.6%) of the recalled drugs were unregistered. This issue is not unique to Saudi Arabia and has also been observed in other countries. Of relevance, in Nepal, where the analysis of drug recall notices issued by the Department of Drug Administration (DDA) between 2010–2020 showed that most recalled drugs were due to product unregistration (26.8%) [ 17 ]. The results indicate that the circulation of unregistered drugs in the market is a serious concern and may be attributed to inadequate monitoring and regulation in certain regions [ 18 ]. The SFDA has the authority to initiate drug recalls for unregistered products, which is within its jurisdiction and responsibilities. This study has several limitations to consider. Firstly, the reliance on retrospective data analysis from drug recall announcements issued by SFDA between July 2016 and December 2022 may introduce potential errors or missing information. The study's analysis focused on recalls reported by the SFDA, leading to potential bias in the selection of recalls. Furthermore, the study did not explicitly investigate the root causes of drug recalls, limiting the understanding of underlying factors. Conclusion In conclusion, this study provides insights into the trends of drug recalls in Saudi Arabia, including the highest year of recalls, the most common therapeutic classes affected, and the primary reasons for recalls. Non-compliance with manufacturer's specifications was found to impact the majority of recalled products. Additionally, innovator pharmaceutical companies were more likely to report drug defects voluntarily compared to generic pharmaceutical companies. Further exploration of the drug recall process is recommended to understand different factors that may influence recall strategies and announcements by the SFDA. Additionally, future studies should assess the impact of drug recalls on the patient care system in Saudi Arabia. Summary and Future Directions Ensuring the control and quality of drug production is becoming increasingly complex. Stringent legislation and inspections of API manufacturing facilities abroad by the SFDA might be necessary. It is advisable for pharmaceutical companies to voluntarily request product recalls as soon as potential threats to public health arise. Moreover, registering all products with the responsible health authorities and encouraging health institutions to exclusively purchase registered products can enhance patient safety. Declarations Author Contributions All authors contributed to the study conception and design [Malak Almutairi], [ Aljoharah Algabbani], [Ajbaa Al Asiri], [Ali Al Homaidan] and [Amani S. AL Qahtani]. Material preparation, data collection and analysis were performed by [Malak Almutairi] data collection was performed by [Ajbaa Al Asiri]. The first draft of the manuscript was written by [Malak Almutairi], and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Conflict of Interest Statement The authors have no conflicts of interest to declare. Funding The authors did not receive support from any organization for the submitted work. Disclaimer The views expressed in this paper are those of the author(s) and not do not necessarily reflect those of the SFDA or its stakeholders. Guaranteeing the accuracy and the validity of the data is the sole responsibility of the research team. Data availability The datasets generated during and/or analyzed during the current study are available in the SFDA Drugs (Circulars and Withdrawal) from National pharmacovigilance and drug safety center (NPC) at SFDA database. References “1 in 10 medical products in developing countries is substandard or falsified.” [Online]. Available: https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified. [Accessed: 26-Mar-2023]. N. N. Borse et al. , “Responding to the surge of substandard and falsified health products triggered by the Covid-19 pandemic,” 2021. S. Ozawa et al. , “Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis,” JAMA Netw. Open , vol. 1, no. 4, Aug. 2018, doi: 10.1001/JAMANETWORKOPEN.2018.1662. “A Guide to Defective Medicinal Products A Guide for Patients, Healthcare Professionals, Manufacturers and Distributors for reporting, investigating and recalling suspected Defective Medicinal Products.uk/government/publications/a-guide-to-defective-medicinal-products website,” 2021. “Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market | FDA.” [Online]. Available: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-fdas-effort-make-more-robust-use-mandatory-recall. [Accessed: 30-Jan-2023]. T. Natof and M. V. Pellegrini, “Food And Drug Administration Recalls,” StatPearls , Sep. 2022. U. Nagaich and D. Sadhna, “Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history,” Int. J. Pharm. Investig. , vol. 5, no. 1, p. 13, 2015, doi: 10.4103/2230-973X.147222. K. Hall, T. Stewart, J. Chang, and M. Kelly Freeman, “Characteristics of FDA drug recalls: A 30-month analysis,” Am. J. Heal. Pharm. , vol. 73, no. 4, pp. 235–240, Feb. 2016, doi: 10.2146/AJHP150277. B. T. AlQuadeib, I. M. Alfagih, A. H. Alnahdi, S. M. Alharbi, and R. A. Al-ahmari, “Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010–January 2019),” Futur. J. Pharm. Sci. , vol. 6, no. 1, Dec. 2020, doi: 10.1186/S43094-020-00112-3. “Pharmacovigilance | Saudi Food and Drug Authority.” [Online]. Available: https://www.sfda.gov.sa/en/pharmacovigilance. [Accessed: 02-Feb-2023]. “Home Page - Tiaquz.” [Online]. Available: https://ade.sfda.gov.sa/. [Accessed: 02-Feb-2023]. “ الإستدعاءات والسحب | Saudi Food and Drug Authority.” [Online]. Available: https://www.sfda.gov.sa/en/drugs_circulars. [Accessed: 24-Jan-2023]. “FDA - Recall Types - FindLaw.” [Online]. Available: https://www.findlaw.com/injury/product-liability/fda-recall-types.html. [Accessed: 02-Feb-2023]. “Anatomical Therapeutic Chemical (ATC) Classification.” [Online]. Available: https://www.who.int/tools/atc-ddd-toolkit/atc-classification. [Accessed: 15-Jan-2023]. A. Morescalchi, F. Nutarelli, and M. Riccaboni, “Product recalls, market size and innovation in the pharmaceutical industry.” “Overview Drugs | Saudi Food and Drug Authority.” [Online]. Available: https://www.sfda.gov.sa/en/overview-drugs. [Accessed: 01-Feb-2023]. A. Neupane, M. Bastakoti, S. Tamang, and B. Giri, “Review of drug recalls and quality of pharmaceutical products in Nepal,” BMJ Open , vol. 12, no. 7, p. e053479, Jul. 2022, doi: 10.1136/BMJOPEN-2021-053479. Y. S. Alruthia et al. , “Drug shortages in Saudi Arabia: Root causes and recommendations,” Saudi Pharm. J. SPJ , vol. 26, no. 7, p. 947, Nov. 2018, doi: 10.1016/J.JSPS.2018.05.002. Tables Table 2: Characteristics of SFDA drug recalls between 2016 and 2022 Reason of recall N (%) Non-compliance with manufacturer's specifications 125 (33.3%) Contamination 89 (23.7%) violations 77 (20.5%) Chemical impurities 38 (10.1%) Contamination and Non-compliance with manufacturer's specifications 28 (7.5%) Packaging defects 8 (2.1%) Failure to demonstrate bioequivalence 4 (1.1%) Incorrect therapeutic dose 3 (0.8%) Not available 3 (0.8%) Type of recall N (%) Batch recall 290 (77.3%) Product recall and registration suspension 52 (13.9%) Product recall 30 (8%) Batch recall and registration suspension 2 (0.5%) Cancel registration of products 1 (0.3%) Number of products included in one report N (%) Reports included one product 147 (77%) Reports included more than one product 44 (23%) Product formulations N (%) Tablets 186 (49.6%) Injectables 99 (26.4%) Syrup 21 (5.6%) Capsules 16 (4.3%) Others 16 (4.3%) Suspension 10 (2.7%) Cream 7 (1.9%) Solution 4 (1.1%) Tablets and Powder 4 (1.1%) Ointment 4 (1.1%) Drops 3 (0.8%) Powder 2 (0.5%) Table 3: Voluntary and Involuntary drug recall requests for defective products between years 2016 and 2022 Year Voluntary recalls N (%) In voluntary recalls N (%) 2016 0 4 (100%) 2017 3 (21.4%) 11(78.6%) 2018 6 (17.1%) 29 (82.9%) 2019 23 (15%) 130 (85%) 2020 7 (14.3%) 42 (85.7%) 2021 10 (11.4%) 78 (88.6%) 2022 15 (46.9%) 17 (53.1%) Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Alqahtani","email":"","orcid":"","institution":"Saudi Food and Drug Authority","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Amani","middleName":"S.","lastName":"Alqahtani","suffix":""}],"badges":[],"createdAt":"2023-07-04 07:24:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3137976/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3137976/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":41088387,"identity":"2d5ea36a-2a69-4ef0-9ad1-899567190f1a","added_by":"auto","created_at":"2023-08-04 17:20:25","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":9423,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePercentage of recalled drugs from the Saudi FDA between 2016 and 2022\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3137976/v1/3a9dd0985c6c1a340fd9ccb1.png"},{"id":41088386,"identity":"ffade9f6-a1fb-40a3-9db7-2e0cccd04b00","added_by":"auto","created_at":"2023-08-04 17:20:25","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":12510,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eMost frequent recalled therapeutic class from 2016 to 2022\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-3137976/v1/ca6965f90b578b7e46d75311.png"},{"id":42664209,"identity":"ed0d4165-ee62-4d2a-8b0f-6707f04dd3df","added_by":"auto","created_at":"2023-09-05 19:55:08","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":562613,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3137976/v1/22479a1f-9ed0-489a-8583-bd5698631e64.pdf"}],"financialInterests":"","formattedTitle":"Content analysis of drug recall announcements in Saudi Arabia: Between 2016 and 2022","fulltext":[{"header":"Introduction","content":"\u003cp\u003e Poor-quality medicines are a significant public health issue, mainly affecting developing countries and impacting their emerging market economies. The World Health Organization (WHO) reports that 1 in 10 substandard medicines is distributed in low- and middle-income countries countries[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The availability of falsified and substandard medicines, whether branded or generic, has become a major concern due to their potential impact on patient health. These substandard medicines can lead to treatment failure, adverse drug reactions, and antimicrobial resistance, resulting in serious health crises [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In fact, it has been estimated that over 116,000 deaths occur annually in sub-Saharan Africa due to substandard and falsified antimalarials, with economic losses exceeding US\u003cspan\u003e$\u003c/span\u003e40\u0026nbsp;million [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe widespread presence of substandard medicines can be attributed to inadequate regulation and governance by regulatory authorities, as well as unethical practices by wholesalers and healthcare practitioners [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].In response, drug regulatory authorities and pharmaceutical companies implement drug recalls as a means to mitigate the impact of substandard medications [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].Drug recalls involve the removal or withdrawal of defective drugs from the market and can be initiated either voluntarily by the company or involuntarily by the public, including healthcare professionals and consumers [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eWhile the number of drug recalls has been increasing in recent years, with a focus on ensuring the safety and efficacy of drugs and medical products for consumers, there is limited research analyzing the patterns and characteristics of drug recall announcements issued by regulatory authorities [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].Previous studies have explored aspects such as patterns of recalls, distribution of recalls among pharmaceutical firms, and the most common reasons for recalls in specific regions like the United States (U.S) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn Saudi Arabia, there has been a notable increase in drug recall trends, particularly in 2018, compared to the previous decade [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, no studies have specifically investigated the patterns of drug recall requests by manufacturers or the public in the country. Therefore, there is a need for regulatory authorities to understand the drug recall process and the behavior of pharmaceutical companies to ensure the safety of products. The aim of this study is to analyze the content of drug recalls issued over a seven-year period by the Saudi Food and Drug Authority (SFDA) and examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects.\u003c/p\u003e"},{"header":"Method","content":"\u003cp\u003eA retrospective data analysis was conducted using drug recall announcements issued by the Saudi Food and Drug Authority (SFDA) between July 2016 and December 2022. Data were collected from the SFDA Drugs Circulars and Withdrawal webpage, which includes registered and unregistered drug recall announcements. The National Pharmacovigilance and Drug Safety Center (NPC) at SFDA provided access to the database for data extraction [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe study included all human drugs that were subject to recall. Two researchers extracted relevant information from the recall announcements, which included data such as recall action date, announcement number, announcement language, number of reported items, product name, therapeutic class, product registration status (registered or unregistered), type of recall, company name, issues identified, recall reasons, drug recall class (I, II, and III) [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], and whether the recall was voluntary or involuntary. Definitions of these groups are shown in (Table-1).\u003c/p\u003e \u003cp\u003eRecall reasons were categorized into groups, including non-compliance with manufacturer's specifications, packaging defects, failure to demonstrate bioequivalence, contamination, chemical impurities, incorrect therapeutic dose, violations, and adverse reactions. The recalls were further classified based on the World Health Organization's Anatomical Therapeutic Chemical (ATC) Classification System [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDescriptive analysis was performed to calculate frequencies and percentages for various data categories, such as the number of drug products, number of recalls reported each year, recall type, product formulation, report classification, reasons for recall, complexity of recalls, registered and unregistered recalls, voluntary and involuntary recalls, therapeutic class, innovator pharmaceutical companies, and generic pharmaceutical companies. Statistical analysis was conducted using SPSS software (version 26.0).\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eBetween July 2016 and December 2022, a total number of 375 products were recalled and analyzed. The highest recall announcements were reported in 2019 [153, (40.8%)] compared to other years (Figuer-1).\u003c/p\u003e \u003cp\u003eThe majority of recalls were involuntary [310, (82.7%)], while [65 ,(17.3%)]of recalls were voluntary. The most voluntary recalls were reported in 2022 [17, (%53)] compared to the past six years (Table-2). In addition, two-thirds [249, (66.4%)] of recalls were related to registered products in the SFDA, unregistered products were accounted for the remaining recalls [126, (33.6%)].\u003c/p\u003e \u003cp\u003eIn terms of the complexity of the reports, the majority of reports included one product [147, (77%)], while 23% (N: 44) reports included more than one product (Table − 2).\u003c/p\u003e \u003cp\u003eThe most common reasons for recalls were as follows: non-compliance with manufacturer's specifications [125, (33.3%)], contamination [89, (23.7%)], violations [77, (20.5%)] and chemical impurities [38, (10.1%)], more details are presented in (Table-3). Most of the recall’s types were identified as batch recall [284, (75.7%)], followed by product recall/ registration suspension [52, (13.9%)], and product recall [30, (8%)] (Table − 2). In terms of product formulations, the majority of recalls were tablets [186, (49.6%)] followed by injectable products [99, (26.4%)] (Table − 2).\u003c/p\u003e \u003cp\u003eForty-one therapeutic classes were found in the product recalled reports; of those, seven therapeutic classes were highlighted as the highest recall frequency throughout the study period (2016–2022) as shown in (Figure − 2). Antacid was reported as the highest-recalled therapeutic class in three different years (2017, 2019 and 2020).\u003c/p\u003e \u003cp\u003eA total of 109 pharmaceutical companies were involved in the recall reports we reviewed. Of those, 14.7% (N: 16) companies were innovator pharmaceutical companies and 85.3% (N: 93) companies were generic pharmaceutical companies. About 68.8% (N:11) of innovator pharmaceutical companies requested voluntary drug recall of defective products whereas 16% (N: 15) of generic pharmaceutical companies requested voluntarily drug recall (Table-3).\u003c/p\u003e "},{"header":"Discussion/Conclusion","content":"\u003cp\u003eThis study aimed to analyze the content of drug recall announcements issued by the SFDA in Saudi Arabia over seven years. The results shed light on the patterns of pharmaceutical companies in requesting voluntary or involuntary drug recalls for defective products and highlight the most frequent causes of drug recalls.\u003c/p\u003e\u003cp\u003eDuring the study period, the highest number of product recalls was reported in 2019. Furthermore, the most frequently recalled therapeutic classes between 2016 and 2022 were antihypertensives and antacids. While these findings indicate an increase in drug recalls, there is insufficient evidence to explain the root cause of this trend. This study shared some similarities with AlQuadeib et al., which showed that the highest recall happened in 2018, and antihypertensives and antibiotics were the most recalled therapeutic classes in Saudi Arabia [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eProduct recalls have a negative impact on the reputation and economic status of companies, including stock prices and sales of affected products [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Interestingly, our results suggest that innovator companies are more likely to voluntarily request a drug recall when a product defect occurs compared to generic companies.\u003c/p\u003e\u003cp\u003eThe SFDA plays a vital role in ensuring the safety of pharmaceutical products and publishing warnings related to defective products [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. In this study, the most common reasons for drug recalls were non-compliance with the manufacturer's specifications (33.3%) and contamination (23.7%). These findings align with previous studies conducted in the United States and Saudi Arabia, highlighting mislabelling and contamination as significant causes of drug recall. Notably, a considerable proportion (33.6%) of the recalled drugs were unregistered. This issue is not unique to Saudi Arabia and has also been observed in other countries. Of relevance, in Nepal, where the analysis of drug recall notices issued by the Department of Drug Administration (DDA) between 2010–2020 showed that most recalled drugs were due to product unregistration (26.8%) [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The results indicate that the circulation of unregistered drugs in the market is a serious concern and may be attributed to inadequate monitoring and regulation in certain regions [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. The SFDA has the authority to initiate drug recalls for unregistered products, which is within its jurisdiction and responsibilities.\u003c/p\u003e\u003cp\u003eThis study has several limitations to consider. Firstly, the reliance on retrospective data analysis from drug recall announcements issued by SFDA between July 2016 and December 2022 may introduce potential errors or missing information. The study's analysis focused on recalls reported by the SFDA, leading to potential bias in the selection of recalls. Furthermore, the study did not explicitly investigate the root causes of drug recalls, limiting the understanding of underlying factors.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn conclusion, this study provides insights into the trends of drug recalls in Saudi Arabia, including the highest year of recalls, the most common therapeutic classes affected, and the primary reasons for recalls. Non-compliance with manufacturer's specifications was found to impact the majority of recalled products. Additionally, innovator pharmaceutical companies were more likely to report drug defects voluntarily compared to generic pharmaceutical companies. Further exploration of the drug recall process is recommended to understand different factors that may influence recall strategies and announcements by the SFDA. Additionally, future studies should assess the impact of drug recalls on the patient care system in Saudi Arabia.\u003c/p\u003e"},{"header":"Summary and Future Directions","content":"\u003cp\u003eEnsuring the control and quality of drug production is becoming increasingly complex. Stringent legislation and inspections of API manufacturing facilities abroad by the SFDA might be necessary. It is advisable for pharmaceutical companies to voluntarily request product recalls as soon as potential threats to public health arise. Moreover, registering all products with the responsible health authorities and encouraging health institutions to exclusively purchase registered products can enhance patient safety.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors contributed to the study conception and design [Malak Almutairi], [ Aljoharah Algabbani], [Ajbaa Al Asiri], [Ali Al Homaidan] and [Amani S. AL Qahtani]. Material preparation, data collection and analysis were performed by [Malak Almutairi] data collection was performed by [Ajbaa Al Asiri]. The first draft of the manuscript was written by [Malak Almutairi], and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no conflicts of interest to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors did not receive support from any organization for the submitted work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDisclaimer\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe views expressed in this paper are those of the author(s) and not do not necessarily reflect those of the SFDA or its stakeholders. Guaranteeing the accuracy and the validity of the data is the sole responsibility of the research team.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated during and/or analyzed during the current study are available in the SFDA Drugs (Circulars and Withdrawal) from National pharmacovigilance and drug safety center (NPC) at SFDA database.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003e\u0026ldquo;1 in 10 medical products in developing countries is substandard or falsified.\u0026rdquo; [Online]. Available: https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified. [Accessed: 26-Mar-2023].\u003c/li\u003e\n\u003cli\u003eN. N. Borse \u003cem\u003eet al.\u003c/em\u003e, \u0026ldquo;Responding to the surge of substandard and falsified health products triggered by the Covid-19 pandemic,\u0026rdquo; 2021.\u003c/li\u003e\n\u003cli\u003eS. Ozawa \u003cem\u003eet al.\u003c/em\u003e, \u0026ldquo;Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis,\u0026rdquo; \u003cem\u003eJAMA Netw. Open\u003c/em\u003e, vol. 1, no. 4, Aug. 2018, doi: 10.1001/JAMANETWORKOPEN.2018.1662.\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;A Guide to Defective Medicinal Products A Guide for Patients, Healthcare Professionals, Manufacturers and Distributors for reporting, investigating and recalling suspected Defective Medicinal Products.uk/government/publications/a-guide-to-defective-medicinal-products website,\u0026rdquo; 2021.\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA\u0026rsquo;s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market | FDA.\u0026rdquo; [Online]. Available: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-fdas-effort-make-more-robust-use-mandatory-recall. [Accessed: 30-Jan-2023].\u003c/li\u003e\n\u003cli\u003eT. Natof and M. V. Pellegrini, \u0026ldquo;Food And Drug Administration Recalls,\u0026rdquo; \u003cem\u003eStatPearls\u003c/em\u003e, Sep. 2022.\u003c/li\u003e\n\u003cli\u003eU. Nagaich and D. Sadhna, \u0026ldquo;Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history,\u0026rdquo; \u003cem\u003eInt. J. Pharm. Investig.\u003c/em\u003e, vol. 5, no. 1, p. 13, 2015, doi: 10.4103/2230-973X.147222.\u003c/li\u003e\n\u003cli\u003eK. Hall, T. Stewart, J. Chang, and M. Kelly Freeman, \u0026ldquo;Characteristics of FDA drug recalls: A 30-month analysis,\u0026rdquo; \u003cem\u003eAm. J. Heal. Pharm.\u003c/em\u003e, vol. 73, no. 4, pp. 235\u0026ndash;240, Feb. 2016, doi: 10.2146/AJHP150277.\u003c/li\u003e\n\u003cli\u003eB. T. AlQuadeib, I. M. Alfagih, A. H. Alnahdi, S. M. Alharbi, and R. A. Al-ahmari, \u0026ldquo;Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010\u0026ndash;January 2019),\u0026rdquo; \u003cem\u003eFutur. J. Pharm. Sci.\u003c/em\u003e, vol. 6, no. 1, Dec. 2020, doi: 10.1186/S43094-020-00112-3.\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;Pharmacovigilance | Saudi Food and Drug Authority.\u0026rdquo; [Online]. Available: https://www.sfda.gov.sa/en/pharmacovigilance. [Accessed: 02-Feb-2023].\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;Home Page - Tiaquz.\u0026rdquo; [Online]. Available: https://ade.sfda.gov.sa/. [Accessed: 02-Feb-2023].\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;\u003cspan dir=\"RTL\"\u003eالإستدعاءات والسحب\u003c/span\u003e | Saudi Food and Drug Authority.\u0026rdquo; [Online]. Available: https://www.sfda.gov.sa/en/drugs_circulars. [Accessed: 24-Jan-2023].\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;FDA - Recall Types - FindLaw.\u0026rdquo; [Online]. Available: https://www.findlaw.com/injury/product-liability/fda-recall-types.html. [Accessed: 02-Feb-2023].\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;Anatomical Therapeutic Chemical (ATC) Classification.\u0026rdquo; [Online]. Available: https://www.who.int/tools/atc-ddd-toolkit/atc-classification. [Accessed: 15-Jan-2023].\u003c/li\u003e\n\u003cli\u003eA. Morescalchi, F. Nutarelli, and M. Riccaboni, \u0026ldquo;Product recalls, market size and innovation in the pharmaceutical industry.\u0026rdquo;\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;Overview Drugs | Saudi Food and Drug Authority.\u0026rdquo; [Online]. Available: https://www.sfda.gov.sa/en/overview-drugs. [Accessed: 01-Feb-2023].\u003c/li\u003e\n\u003cli\u003eA. Neupane, M. Bastakoti, S. Tamang, and B. Giri, \u0026ldquo;Review of drug recalls and quality of pharmaceutical products in Nepal,\u0026rdquo; \u003cem\u003eBMJ Open\u003c/em\u003e, vol. 12, no. 7, p. e053479, Jul. 2022, doi: 10.1136/BMJOPEN-2021-053479.\u003c/li\u003e\n\u003cli\u003eY. S. Alruthia \u003cem\u003eet al.\u003c/em\u003e, \u0026ldquo;Drug shortages in Saudi Arabia: Root causes and recommendations,\u0026rdquo; \u003cem\u003eSaudi Pharm. J. SPJ\u003c/em\u003e, vol. 26, no. 7, p. 947, Nov. 2018, doi: 10.1016/J.JSPS.2018.05.002.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cimg src=\"https://myfiles.space/user_files/122228_c8a1650c59388082/122228_custom_files/img1691101085.png\"\u003e\u003c/p\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eTable 2: Characteristics of SFDA drug recalls between 2016 and 2022\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable style=\"width:473.25pt;border-collapse:collapse;border:none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border: 1pt solid windowtext;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 18.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003eReason of recall\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 18.6pt;vertical-align: bottom;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003eN (%)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 5.3pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eNon-compliance with manufacturer\u0026apos;s specifications\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 5.3pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;color:black;'\u003e125 (33.3%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 8.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eContamination\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 8.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e89 (23.7%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 8.2pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eviolations\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 8.2pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e77 (20.5%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 11.45pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eChemical impurities\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 11.45pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e38 (10.1%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eContamination and Non-compliance with manufacturer\u0026apos;s specifications\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;color:black;'\u003e28 (7.5%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003ePackaging defects\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e8 (2.1%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eFailure to demonstrate bioequivalence\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;color:black;'\u003e4 (1.1%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eIncorrect therapeutic dose\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e3 (0.8%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eNot available\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 12.55pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;color:black;'\u003e3 (0.8%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eType of recall\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 13.6pt;vertical-align: bottom;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eN (%)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eBatch recall\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;color:black;'\u003e290 (77.3%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eProduct recall and registration suspension\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e52 (13.9%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eProduct recall\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;color:black;'\u003e30 (8%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eBatch recall and registration suspension\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e2 (0.5%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eCancel registration of products\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;color:black;'\u003e1 (0.3%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eNumber of products included in one report\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eN (%)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eReports included one product\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e147 (77%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eReports included more than one product\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height: 150%;font-family:\"Times New Roman\",serif;color:black;'\u003e44 (23%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eProduct formulations\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eN (%)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eTablets\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e186 (49.6%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eInjectables\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e99 (26.4%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eSyrup\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e21 (5.6%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eCapsules\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;'\u003e16 (4.3%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eOthers\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e16 (4.3%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eSuspension\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;'\u003e10 (2.7%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eCream\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e7 (1.9%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eSolution\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;'\u003e4 (1.1%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eTablets and Powder\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e4 (1.1%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eOintment\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;'\u003e4 (1.1%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003eDrops\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003e3 (0.8%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 302.75pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:150%;font-family:\"Times New Roman\",serif;'\u003ePowder\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 170.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 13.6pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:13px;line-height:150%;font-family: \"Times New Roman\",serif;'\u003e2 (0.5%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:150%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:justify;'\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:16px;line-height:115%;font-family:\"Times New Roman\",serif;'\u003eTable 3: Voluntary and Involuntary drug recall requests for defective products between years 2016 and 2022\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable style=\"width:467.5pt;border-collapse:collapse;border:none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 94.7pt;border: 1pt solid windowtext;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 32.35pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003eYear\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 164.3pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 32.35pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003eVoluntary recalls\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:11px;line-height:115%;font-family:\"Times New Roman\",serif;color:black;'\u003eN (%)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208.5pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;background: rgb(217, 217, 217);padding: 0in 5.4pt;height: 32.35pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003eIn\u0026nbsp;voluntary recalls\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:11px;line-height:115%;font-family:\"Times New Roman\",serif;color:black;'\u003eN (%)\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 94.7pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times 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style='font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp;6 (17.1%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e29 (82.9%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 94.7pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp 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0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e130 (85%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 94.7pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e2020\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 164.3pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 15pt;vertical-align: bottom;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp;7 (14.3%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e42 (85.7%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 94.7pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e2021\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 164.3pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 15pt;vertical-align: bottom;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp;10 (11.4%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e78 (88.6%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 94.7pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e2022\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 164.3pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 15pt;vertical-align: bottom;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp;15 (46.9%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208.5pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 15pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;color:black;'\u003e17 (53.1%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp style='margin-top:0in;margin-right:0in;margin-bottom:10.0pt;margin-left:0in;line-height:115%;font-size:15px;font-family:\"Calibri\",sans-serif;'\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Drug recalls, Recalls announcement, SFDA, Pharmaceutical companies","lastPublishedDoi":"10.21203/rs.3.rs-3137976/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3137976/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eThis study aims to analyze drug recall reports issued by the Saudi Food and Drug Authority (SFDA) in Saudi Arabia over seven years and describe the practice of pharmaceutical companies regarding voluntary drug recalls.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA retrospective data analysis was conducted on drug recall announcements issued by the SFDA between July 2016 and December 2022. The study included registered and unregistered drug recalls posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on variables such as recall year, report language, number of report items, depth of recall, product name, therapeutic class, product registration status, recall type, pharmaceutical company type, recall reasons, and voluntary or involuntary product defect reports.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eDuring the study period, a total of 375 products were recalled, with the majority being involuntary recalls (82.7%). Over two-thirds of the recalls (66.4%) were related to registered products. The most common reasons for recalls were non-compliance with manufacturer's specifications (33.3%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recall of defective products. Innovator pharmaceutical companies tended to request voluntary recalls more often than generic pharmaceutical companies.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Innovator pharmaceutical companies were more likely to request voluntary recalls for product defects compared to generic pharmaceutical companies.\u003c/p\u003e","manuscriptTitle":"Content analysis of drug recall announcements in Saudi Arabia: Between 2016 and 2022","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-08-04 17:20:20","doi":"10.21203/rs.3.rs-3137976/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e9660760-1c03-4a2a-8a79-bfa54ba24256","owner":[],"postedDate":"August 4th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2023-09-05T19:47:01+00:00","versionOfRecord":[],"versionCreatedAt":"2023-08-04 17:20:20","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3137976","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3137976","identity":"rs-3137976","version":["v1"]},"buildId":"ehx78VzkSd0WSzXnipQa-","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}