Health Canada Issues Recall of Apotex`s Apo-Acyclovir Tablets
Nitrosamines such as N-nitrosodimethylamine (NDMA) have become common culprits for recalls of various drug products, including sartans for hypertension, metformin for diabetes and ranitidine for heartburn. As a result, regulators require frequent testing for nitrosamines in drug substances and finished products.
Nitrosamine impurities have sparked numerous recalls over the past couple of years; however, prior to the recalls in 2020, Official Medicines Control Laboratories (OMCLs) from the OMCL Network participated in an international collaboration of regulatory laboratories to analyse metformin APIs and drug products.
Apotex Inc. is recalling certain lots of Apo-Acyclovir (acyclovir) tablets, in 200 mg and 800 mg strengths, due to the presence of a nitrosamine impurity (N-nitrosodimethylamine [NDMA]) above the acceptable level.
On Monday, the Ministry of Food and Drug Safety issued a recall order for a batch of Medica Korea’s Zatidine Capsule 150mg (Nizatidine) and Hutecs Korea Pharmaceutical’s Acitidine Capsule.
Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets
Viona Pharma Issues Voluntary Nationwide Recall of Metformin HCl ER Tablets for NDMA Impurity
Health Canada Pharmascience Inc.Recalls of PMS-Ranitidine 150mg
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA).