Drug 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
D-0701-2021
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 88077
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 69,6396 bottles
- Official record key
drug-enforcement:D-0701-2021
Official wording
Reason: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Code information: Lots EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 2023.
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-varenicline impurity
-
Manufacturing or process control
CGMP Deviations