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Two Lots of Quinapril and Hydrochlorothiazide 20mg/12.5mg Tablets Recalled

On October 24, 2022, Aurobindo Pharma USA, Inc. initiated a voluntary recall of two lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit.

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

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 are 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 count high density polyethylene (HDPE) bottles.

Consumers withmedical questions regarding this recall or to report an adverse eventcan contact Aurobindo Pharma USA, Inc. at:

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. Any general questions regarding the return of this product please contact Qualanex at 1-888-504-2014 (live calls received 8:00 am to 5:00 pm M-F EST).

Source:

  1. FDA MedWatch. Recalls, Market Withdrawals, & Safety Alerts. Retrieved October 26, 2022 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and?utm_medium=email&utm_source=govdelivery
Published on: October 31, 2022, 01:31 a.m. ET
Last updated on: October 27, 2022, 09:37 a.m. ET