Aurobindo Pharma USA, Inc., affiliated to Indian pharma major Aurobindo Pharma Limited, is recalling two lots of Quinapril and Hydrochlorothiazide tablets due to the presence of Nnitroso-quinapril, a probable human carcinogen, the U.S. Food and Drug Administration said.
Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide.
The tablets are indicated for the treatment of hypertension, to lower blood pressure.
The recall involves Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, supplied in 90’s HDPE bottle, with lot code QE2021005-A and QE2021010-A, and expiry of 01/2023.
The tablets are pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ’19’on other side”.
Aurobindo Pharma USA began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.
The recall to the consumer level from the US market was due to the presence of Nitrosamine Drug Substance Related Impurity or 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. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
However, East Windsor, New Jersey -based Aurobindo Pharma USA has not received any reports of adverse events related to the recall to date.
Patients are asked to contact their doctor or health care provider about continuing their medication, or considering an alternative treatment prior to returning their medication.
In April, drug major Pfizer Inc. recalled five lots of Accupril (Quinapril HCl) tablets due to the presence of a nitrosamine, Nnitroso-quinapril.
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