Enforcement Report - Week of December 28, 2022
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril
Enforcement Report - Week of November 2, 2022
In the words of Daft Punk, one more time. On October 25, the U.S. Food and Drug Administration (FDA) announced yet another blood pressure medicine recall for contaminants that may cause cancer, a problem that has occurred far too many times since 2017. This time the company is Aurobindo Pharma USA, Inc. The blood pressure medication being recalled is Quinapril and Hydrochlorothiazide Tablets USP in 20 mg and 12.5 mg doses, respectively. And the contaminant is Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril in levels that exceed acceptable limits.
Indian generics manufacturer Aurobindo is having to pull another product off the shelves.
Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide
Enforcement Report - Week of May 25, 2022
Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL
Health Canada Issues Recall Pfizer Canada ULC. Accupril Tabs: Nitrosamine impurity
Enforcement Report - Week of April 13, 2022