Hyderabad-based Aurobindo Pharma has recalled its products in the US markets due to manufacturing lapses. The latest Enforcement Report by the US Food and Drug Administration (USFDA) stated that Aurobindo Pharma USA Inc which is based in New Jersey has recalled 9,504 bottles of Quinapril and Hydrochlorothiazide tablets.
These drugs used to treat high blood pressure are manufactured in India and marketed in the US by Aurobindo Pharma. The recalling happened due to the detection of N-Nitroso-quinapril impurity above the acceptable daily limit. Nitrosamines can cause damage to the DNA in the long term.
USFDA has issued a separate statement that AuroMedics Pharma LLC, a unit of Aurobindo Pharma has recalled 11,520 units of Fondaparinux sodium injection from the US markets as well.
The US drug market is the largest for pharmaceutical products.
