Product: Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only,  Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03.  EXPIRATION DATE: September 2021   June 2023
Reason for recall: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Recall initiated: 20210813
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated