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Recall: Two Lots of Quinapril and Hydrochlorothiazide 20mg/12.5mg Tablets, Due to the Detection of N-Nitroso Quinapril Impurity

On October 24, 2022, Aurbindo USA, Inc. initiated a voluntary recall of two 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.

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

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).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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, 01:39 a.m. ET
Last updated on: October 27, 2022, 09:19 a.m. ET