Drug product
TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
D-0533-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 tubes
- Official record key
drug-enforcement:D-0533-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 20B14E
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations