FDA-Drug2021-09-29Class 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
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-0809-2021Don't want to check this manually?
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