Drug product
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
D-0699-2021
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 88077
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 59,232 bottles
- Official record key
drug-enforcement:D-0699-2021
Official wording
Reason: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Code information: Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-varenicline impurity
-
Manufacturing or process control
CGMP Deviations