Aurobindo Pharma recalls products in US market

The pharma company has initiated a voluntary recall of two lots of blood pressure drug quinapril and hydrochlorothiazide tablets due to presence of Nitrosamine Drug Substance Related Impurity or NDSRI above the proposed interim limit.

Nitrosamines are commonly found in water and foods.

Exposure to such impurities, if above the acceptable levels or over a long period of time, may increase the risk of cancer.

The federal agency has said that to date, Aurobindo Pharma has not received any reports of adverse events related to this recall.

The East Windsor-based drug firm is recalling the affected lot due to the "presence of particulate matter: piece of metal found in a vial", the USFDA stated. AuroMedics commenced the Class III recall in the US on September 26.

In September, the US drug regulator had issued Form 483. It was inspected earlier in 2018-2019 as well and the form was issued and official action indicated status in 2019, which was then turned into a warning letter in 2019. So it has had a warning letter on it.

The USFDA inspected the company's Unit XI, an Active Pharmaceutical Ingredient non-antibiotic manufacturing facility at Pydibhimavaram in Andhra Pradesh's Srikakulam district, from July 25 to August 2, 2022.