Direct Rx: Drug Recall
Recall #D-1535-2022 · 09/12/2022
Class II: Risk
Recall Details
- Recall Number
- D-1535-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Direct Rx
- Status
- Completed
- Date Initiated
- 09/12/2022
- Location
- Dawsonville, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 tubes
Reason for Recall
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
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.
Distribution Pattern
Physicians and Medical Facilities in GA and ID
Other Recalls by Direct Rx
- Class II: Risk 03/07/2025
- Class II: Risk 03/07/2025
- Class II: Risk 01/31/2025
- Class II: Risk 08/09/2024
- Class II: Risk 03/22/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.