Drug product
PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
D-0460-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 bottles
- Official record key
drug-enforcement:D-0460-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: ABA4203A1
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations