Aurobindo Pharma recalls units in US citing issues

NEW DELHI: Aurobindo Pharma units are recalling different products in the US market for manufacturing lapses, as per the US health regulator.

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 affected lot of the medication, which is used to treat high blood pressure, has been manufactured in India and marketed in the US market by Aurobindo Pharma USA, Inc.

The company is recalling the affected lot due to “Current good manufacturing practices CGMP deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.” Nitrosamines are a group of compounds which can damage DNA in the long term. The company, a unit of Hyderabad-based Aurobindo Pharma, initiated the Class II voluntary recall on October 5 this year.

USFDA said AuroMedics Pharma LLC, a unit of Aurobindo Pharma, is recalling 11,520 units of Fondaparinux Sodium Injection in the US market. The medication, an anticoagulant, is used in the treatment of deep vein thrombosis. As per the USFDA, the company is recalling the affected units due to it being “Subpotent Drug: Out of specification for assay”.

AuroMedics Pharma LLC initiated the Class II recall for the affected lot across the US on Sept 30 this year. As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.