Pfizer Inc. recalls Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfiz
Recalled September 29, 2021 · FDA recall D-0811-2021 · Pfizer
Hazard
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit · FDA Class II
Sold at
Nationwide
Description
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
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
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →