Drug product
CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS
D-0520-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 407 BOXES
- Official record key
drug-enforcement:D-0520-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: FG12532
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations