Drug product
HYDROCORTISONE 1% 30gm cream
D-0565-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 143 tubes
- Official record key
drug-enforcement:D-0565-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: KK4912
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations