D-1535-2022 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- September 21, 2022
- Initiation Date
- September 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 tubes
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.
Reason for Recall
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Distribution Pattern
Physicians and Medical Facilities in GA and ID
Code Information
Lot: 12JY2216, Exp. 2/29/24