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 A ..
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 ..
