Class II Recall

Pfizer Inc.

Product
Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56
Reason
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Classification
Class II
Status
Ongoing
Lot
Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.