Pfizer Inc. recalls Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10
Recalled August 11, 2021 · FDA recall D-0701-2021 · Pfizer
Hazard
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit · FDA Class II
Units
69,6396 bottles
Sold at
Nationwide
Description
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Product
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →