Drug product
ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS
D-0440-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1935 bottles
- Official record key
drug-enforcement:D-0440-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: ON0420015-A
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations