Drug product
UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS
D-0415-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 964 bottles
- Official record key
drug-enforcement:D-0415-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 1658641
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations