HQ Team
October 26, 2022: Aurobindo Pharma US has initiated a voluntary recall of two lots of tablets in the American market due to the risk of cancer-causing impurities.
The two tablets, Quinapril and Hydrochlorothiazide USP 20mg /12.5mg, were recalled from the US market due to the presence of nitrosamine drug substance-related impurity, N-Nitroso-Quinapril, above the proposed interim limit.
Aurobindo began shipping to customers nationwide in May 2021.
Pharma companies began to include USP on their product labels to indicate to pharmacists, medical practitioners and patients that the quality standards made the product of the United States Pharmacopeia.
Water, food
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables, according to a statement from USFDA issued on October 24.
Everyone gets exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods.
Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.
Quinapril and Hydrochlorothiazide Tablets, are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide.
Lower blood pressure
This drug is indicated for the treatment of hypertension to lower blood pressure.
Qualanex, on behalf of Aurobindo Pharma USA, will notify its distributors and customers to immediately discontinue distribution of the specific lots recalled and notify their sub-accounts.
Aurobindo Pharma USA, Inc. is arranging for the return of all recalled products to Qualanex. According to the statement, the U.S. Food and Drug Administration is aware of this recall.
