Safety Report: Aurobindo Pharma Quinapril and Hydrochlorothiazide Tablets - recalled due to due to presence of impurities, USA

United States

East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit. Aurobindo Pharma USA, Inc. began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.

-Affected product:
NDC No.: 65862-162-90, Product Name, strength, and pack: Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle, Lot number: QE2021005-A; QE2021010-A, Expiry: 01/2023

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

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. 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.

Quinapril and Hydrochlorothiazide Tablets USP 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.

Qualanex, on behalf of Aurobindo Pharma USA, Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Aurobindo Pharma USA, Inc.
Brand name: Aurobindo Pharma USA, Inc.
Product recalled: Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle
Reason of the recall: Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril
FDA Recall date: October 25, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and