Aurobindo Pharma units recall products in US over manufacturing lapses

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.

As per the USFDA, 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.

In a separate statement, 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".

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AuroMedics Pharma LLC initiated the Class II recall for the affected lot across the US on September 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 temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products