Class II
Ongoing
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
- Company
- Pfizer Inc.
- Recall Initiated
- June 9, 2021
- Posted
- August 11, 2021
- Recall Number
- D-0699-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 59,232 bottles
- Firm Location
- New York, NY, United States
Reason for Recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Distribution
Nationwide
Lot / Code Info
Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023
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