Drug product
Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36
D-0551-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 178 tubes
- Official record key
drug-enforcement:D-0551-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 0MT0286
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations