Lupin Pharmaceuticals has voluntarily recalled 4 lots of Quinapril Tablets to the consumer level due to the presence of a nitrosamine impurity, N-nitroso-quinapril, above the Food and Drug Administration’s (FDA) acceptable daily limit.

The recalled lot of Quinapril Tablets USP 20mg; NDC Number 68180-558-09; Lot Number G102929; Exp Date 4/2023, is supplied in 90-count bottles. The recalled lots of Quinapril Tablets USP 40mg; NDC Number 68180-554-09; Lot Number G100533 (Exp Date 12/2022), G100534 (Exp Date 12/2022), G203071 (Exp Date 3/2024), are supplied in 90-count bottles. These recalled products were distributed between March 15, 2021 to September 1, 2022.

The recalled labels. Credit: Lupin Pharmaceuticals.

Quinapril Tablet is 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

Lupin Pharmaceuticals, Inc. issues voluntary nationwide recall of four lots of quinapril tablets due to potential presence of N-Nitroso-Quinapril Impurity. News release. Lupin Pharmaceuticals, Inc. Accessed December 21, 2022. https://www.prnewswire.com/news-releases/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-of-four-lots-of-quinapril-tablets-due-to-potential-presence-of-n-nitroso-quinapril-impurity-301708438.html.