Aurobindo Pharma USA has voluntarily recalled 2 lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg due to the presence of a nitrosamine impurity, N-nitroso-quinapril, above the Food and Drug Administration’s (FDA) proposed interim limit.

The recalled lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg; NDC Number 65862-162-90; Lot Numbers QE2021005-A and QE2021010-A; Expiration Date 01/2023, are supplied in 90-count bottles and were distributed nationwide in May 2021.

Quinapril and Hydrochlorothiazide Tablet is a fixed-combination tablet indicated for the treatment of hypertension. Long-term use of a product containing N-nitroso-quinapril may be associated with an increased cancer risk based on data from closely related nitrosamine compounds. To date, the Company has not received any reports of adverse events related to this recall. 

Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.

Reference

Aurobindo Pharma USA, Inc. initiates voluntary nationwide recall of two (2) lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, due to the detection of N-nitroso quinapril impurity. News release. Aurobindo Pharma USA, Inc. October 24, 2022. Accessed October 26, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and