Aurobindo Pharma units are recalling various products in the US market for manufacturing defects, according to the US health department.
According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), New Jersey-based Aurobindo Pharma USA Inc is recalling 9,504 bottles of Quinapril and Hydrochlorothiazide tablets.
The most affected drug, which is used to treat high blood pressure, is manufactured in India and sold in the US market by Aurobindo Pharma USA, Inc.
According to the USFDA, the company is recalling the defect due to “Current good manufacturing practice CGMP deviation: Detection of N-Nitroso-quinapril impurity above the acceptable daily limit.”
Nitrosamines are a group of compounds that can cause long-term damage to DNA. The company, part of Hyderabad-based Aurobindo Pharma, initiated a Class II voluntary recall on October 5 this year.
In another statement, the USFDA said AuroMedics Pharma LLC, a division of Aurobindo Pharma, is recalling 11,520 units of Fondaparinux Sodium Injection from the US market. The drug, an anticoagulant, is used in the treatment of deep vein thrombosis. According to the USFDA, the company is recalling the affected parts due to its being a “Subpotent Drug: Outside the specification of the assay”.
AuroMedics Pharma LLC initiated a Class II recall for the affected lot in the US on September 30 this year.
According to the USFDA, a Class II recall is initiated in situations where use of, or exposure to, the infringing product may cause temporary or reversible health effects or there is a possibility of serious health effects in the long run.
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.