Drug product
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
D-1497-2022
Product summary
- Firm
- Padagis US LLC
- Event
- Event 90790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57,816 tubes
- Official record key
drug-enforcement:D-1497-2022
Official wording
Reason: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Code information: Lot 2CT0486 , Exp 02/29/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations