Recalls / Class II
Class IID-1535-2022
Product
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
- Brand name
- Triamcinolone Acetonide
- Generic name
- Triamcinolone Acetonide Cream
- Active ingredient
- Triamcinolone Acetonide
- Route
- Topical
- NDC
- 72189-330
- FDA application
- ANDA086413
- Affected lot / code info
- Lot: 12JY2216, Exp. 2/29/24
Why it was recalled
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 20 tubes
- Distribution pattern
- Physicians and Medical Facilities in GA and ID
Timeline
- Recall initiated
- 2022-09-12
- FDA classified
- 2022-09-15
- Posted by FDA
- 2022-09-21
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1535-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.