The pharmaceutical industry's primary concern is to provide high-quality drug products to the general public, so drug recalls play an important role in maintaining the quality system by removing defective products from the market. Pharmaceutical product recalls are increasing at an alarming rate as a result of increased inspection rates and the introduction of modernization and the digital world into the industry, raising concerns for regulatory agencies and public health to focus on more stringent regulations to control future recalls of defective drug products. This article will provide an overview of recall procedures, their impact on the pharmaceutical industry, and the various steps taken to reduce pharmaceutical recalls.
FoodT. U. S. differences among FDA class I, II, and III recalls get the compensation you deserve. 2020; 1–3.
4.
Examples of different classes of recall action 27. 2020; 1–4.
5.
Food and Drug Administration (FDA). CFR – Code of Federal Regulations Title 21 The information on this page is current as of April 1 2016. 2017; 721: 1–10.
6.
LuxminarayanLNehaSAmitV, et al. Asian journal of pharmaceutical research and development. Asian J Pharm Res Dev2017; 5: 1–8.
7.
ArticleR.Findings and regulatory inspections of USFDA form 483. 2020; 61: 83–87.
VenkateshMPBigoniyaDPramodT.Pharmaceutical product recall procedures in India, South Africa and China. Int J Pharm Sci Rev Res2017; 46: 98–104.
11.
YangMByrnSRClaseKL.An analytic investigation of the drug formulation-based recalls in the USA: see more beyond the literal. AAPS PharmSciTech2020; 21: 1–10.
12.
Announcement, C. Fresenius Kabi issues voluntary nationwide recall of ketorolac tromethamine injection, USP due to the presence of particulate matter. 2021; 2019–2022.
13.
Announcement, C. Innoveix Pharmaceuticals, Inc. issues voluntary recall of all sterile compounded drug products due to a lack of sterility assurance. 2021; 3–5.
14.
Announcement, C. A & H Focal Inc. issues nationwide recall of 21 products marketed as dietary supplements & one cosmetic product due to the possible presence of undeclared erectile dysfunction ingredients. 2021; 2–4.
15.
AdamsonRHChabnerBA.The finding of N‐nitrosodimethylamine in common medicines.Oncologist2020; 25: 460–462.
16.
TavaresMKozakMBalolaA, et al. Burkholderia cepacia complex bacteria: a feared contamination risk in water-based pharmaceutical products. Clin. Microbiol. Rev2020; 33: 1–25.
TawdeSA.Particulate matter in injectables: main cause for recalls. J Pharmacovigil2015; 3: 1–2.
20.
Desmukh MTSalunkhe RS, Deshmukh VT and Shete RV. Quality control test’s for parenteral preparations: a review. J Curr Pharm Res2015; 5: 1425–1430.
21.
KolluruLP.Sterility assurance of parenteral products – major deficiency for recall. 2017; 5: 4–5.
22.
FDA.Sterile drug products current good manufacturing practice guidance for industry. Filtration2004; 1–63.
23.
NewMWithoutD. Guidance for FDA staff and industry marketed unapproved drugs – compliance policy guide guidance for FDA staff and industry marketed unapproved drugs – compliance policy guide. Fed Regist 2006; 1–15.
24.
ShaikKMSarmahBWadekarGS, et al. Regulatory updates and analytical methodologies for nitrosamine impurities detection in sartans, ranitidine, nizatidine, and metformin along with sample preparation techniques. Epub ahead of print. Crit Rev Anal Chem 2020; 1–19.
25.
European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5 (3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines. 2021; 5.
26.
MugoyelaVMugoyelaVMwambeteKD.Microbial contamination of nonsterile pharmaceuticals in public hospital settings. Ther Clin Risk Manag2010; 443–448.
QuanhongLXinZ.Corporate product recall and its influence on corporate performance. 2015; 241–246.
30.
A list of the non-selective NSAIDs is available onhttp://www.fda.gov/cder/drug/infopage/cox2/default.htm. The degree of COX-2 selectivity for any given drug has not been definitively established, and there is considerable overlap in. 2005; 1–19.
31.
MgMTmPKMpV. Biological and chemical sciences regulation of reverse logistics of pharmaceutical products in United States. Res J Pharm 8: 2017. 315–320.
32.
ShewaleSDChavanMParekhSS.Pharmaceutical product recall: lesson learned. Int Pharm Ind2014; 6(1), 1–23.
