On October 25, 2022, the U.S. Food and Drug Administration (FDA) affirmed another blood pressure medicine recalled due to carcinogen contamination. This recall joins the growing list of medications recalled due to Nitrosamine contamination. Nitrosamine is a known carcinogen that could cause cancer if consumed over an extended time period. The FDA’s warning letter states that Aurobindo Pharma USA, Inc has initiated a recall of its blood pressure medications 20 mg Quinapril and 12.5 mg Hydrochlorothiazide Tablets USP. According to the FDA’s recall announcement, the contaminant discovered is a Nitrosamine Drug Substance Related Impurity (NDSRI) called N-Nitroso-Quinapril. The N-Nitroso-Quinapril contamination was found to be at levels that exceeded the FDA’s acceptable limits.
Although nitrosamines, like N-Nitroso-Quinapril, are found in food and water, such as dairy products, grilled or cured meats, and vegetables, consuming nitrosamines over a long period of time increases the risk of developing cancer. The FDA established acceptable levels of nitrosamines in medications. Right now, Aurobindo Pharma USA, Inc. is not reporting that they have received any reports of adverse events connected with this medication recall. However, the high presence of nitrosamines means the company will need to correct its manufacturing processes.
This recall does not affect all blood pressure medications. The recall only includes certain lots of the Hydrochlorothiazide and Quinapril Tablets USP distributed by Aurobindo Pharma USA, Inc. The affected lots have lot numbers QE2021005-A or QE2021010-A and were shipped from May 2021 until October 2022. The national drug code (NDC) number is 65862-162-90, and the recalled medications have an expiry date of 01/2023. The tablets are described as film-coated, round, pink-colored, biconvex, with a “19” imprinted on one side and a “D” on the tablet’s other side. If you are unable to determine if your medication has been recalled, contact your pharmacist for additional assistance.
The FDA is advising that those with the recalled medication should contact their doctor for help and to continue to take their blood pressure medication as prescribed. Stopping your blood pressure medication could cause dangerous blood pressure spikes. After you and your doctor discuss your medication, you might receive an important phone call from Qualanex concerning the recall.
This blood pressure medication recall shows that the government needs to do a better job at ensuring medications are safely manufactured. As drug manufacturers expand their supply chains throughout the world in hopes of lower their cost of manufacturing, the government must ensure regulations are being followed, and plant inspections continue. Medication defects are not as easy to recognize, leading to negative health consequences.
Aurobindo Pharma USA, Inc. urges patients who are prescribed one of the recalled products to consult with their doctor or pharmacy to see if they have a recalled product.
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