Drug product
SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS
D-0450-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67 BOXES
- Official record key
drug-enforcement:D-0450-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 2003060A
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations