FDA-Drug2021-08-11Class II
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
Pfizer Inc.
Hazard
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Sold states
Nationwide
Affected count
59,232 bottles
Manufactured in
235 East 42nd Street, New York, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0699-2021Don't want to check this manually?
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