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 for recall: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Recall initiated: 20210609
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated