Drug product
PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES
D-0501-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 bottles
- Official record key
drug-enforcement:D-0501-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 16667A
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations