Drug Safety Alerts

Quinapril and Hydrochlorothiazide Tablets Voluntary Recall

10/25/2022

On October 25, 2022, the United States Food & Drug Administration (FDA) published a consumer-level recall of Quinapril and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 90’s HDPE bottle NDC #65862-0162-90 distributed Aurobindo Pharma USA, Inc. This recall was issued due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot numbers QE2021005-A & QE2021010-A exp. 01/2023.

Aurobindo’s Risk Statement: Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is 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 of time. Aurobindo Pharma USA, Inc. has advised that it has not received any reports of adverse events related to this recall.

These Aurobindo Quinapril and Hydrochlorothiazide Tablets are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of hypertension, to lower blood pressure. Aurobindo is advising patients to contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.

These Aurobindo Quinapril and Hydrochlorothiazide Tablets 20 mg/12.5 mg are “Pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ‘19’on other side”, supplied in 90’s HDPE bottle.

Aurobindo has advised that consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Quinapril & Hydrochlorothiazide Tablets, 20 mg/12.5 mg to contact their prescriber.

For more information about the [action taken], please call Aurobindo Pharma USA, Inc. toll-free at 1-866-850-2876 (Option 2), 24 hours per day, 7 days per week or email pvg@aurobindousa.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.