Drug product
LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES
D-0492-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 298 bottles
- Official record key
drug-enforcement:D-0492-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: AB1024A
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations