FDA MedWatch – Two Lots of Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg by Aurobindo Pharma USA

TOPIC: Two Lots of Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg by Aurobindo Pharma USA: Recall – Due to the Detection of N-Nitroso Quinapril Impurity

AUDIENCE: Patient, Consumer, Health Professional, Pharmacy

ISSUE: Aurobindo Pharma USA is recalling of two (2) lots of Quinapril and Hydrochlorothiazide Tablets, USP 20mg /12.5mg due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit.

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.

To date, Aurobindo Pharma USA has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: Quinapril and Hydrochlorothiazide Tablets, USP 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.

RECOMMENDATIONS: 

• Patients should 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.
• 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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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