Recalls / Class II
Class IID-1497-2022
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.
- Brand name
- Triamcinolone Acetonide
- Generic name
- Triamcinolone Acetonide
- Active ingredient
- Triamcinolone Acetonide
- Route
- Topical
- NDCs
- 45802-063, 45802-064, 45802-065
- FDA application
- ANDA086413
- Affected lot / code info
- Lot 2CT0486 , Exp 02/29/2024
Why it was recalled
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Recalling firm
- Firm
- Padagis US LLC
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3940 Quebec Ave N, Minneapolis, Minnesota 55427-1244
Distribution
- Quantity
- 57,816 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-08-17
- FDA classified
- 2022-09-07
- Posted by FDA
- 2022-09-07
- Terminated
- 2023-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1497-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.