Drug product
Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56
D-0555-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 848 bottles
- Official record key
drug-enforcement:D-0555-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: EM1069
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations