Impurities Lead to Recall of Two Lots of Quinapril/Hydrochlorothiazide

The recall was triggered by the presence of nitrosamine above the proposed limit.

Aurobindo Pharma USA has recalled two lots of Quinapril and Hydrochlorothiazide Tablets because of the presence of nitrosamine above the proposed limit. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. But nitrosamine is generally considered carcinogenic, especially if present in high concentrations over time.

To date, Aurobindo Pharma 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. This product is indicated for the treatment of hypertension.

The product under recall is 20 mg / 12.5 mg and are pink colored, scored, round shaped, debossed with ‘D’ on scored side and ‘19’on other side. It is supplied in 90s HDPE bottle.

The NDC number 65862-162-90, and the lots affected are QE2021005-A and QE2021010-A, both with an expiration date of January 2023. The product was distributed in May 2021.