Status
Completed
Drug Enforcement D-1535-2022
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
1 Views
Classification
Class II
Report Date
September 21, 2022
Termination Date
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Product Information
- Product description
- 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.
- Product quantity
- 20 tubes
- Reason for recall
- CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Physicians and Medical Facilities in GA and ID
Location & Firm
- Recalling firm
- Direct Rx
- Address
-
94 Worldwide Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1535-2022
- Event ID
- 90869
- Recall initiation date
- September 12, 2022
- Center classification date
- September 15, 2022
- Code info
- Lot: 12JY2216, Exp. 2/29/24
- More code info
- —