TRIAMCINOLONE ACETONIDE Recall D-1535-2022
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.
TRIAMCINOLONE ACETONIDE Recall D-1535-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1535-2022 |
| Event ID | 90869 |
| Brand | TRIAMCINOLONE ACETONIDE |
| Generic Name | TRIAMCINOLONE ACETONIDE CREAM |
| Manufacturer | TRIAMCINOLONE ACETONIDE CREAM |
| Active Substance | TRIAMCINOLONE ACETONIDE |
| Drug Route | TOPICAL |
| Distribution | Physicians and Medical Facilities in GA and ID |
| Quantity | 20 tubes |
| Recall Reason | CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. |
| Drug Classification | Class II |
| Drug Code Info | 20220921 |
| Product NDC | 72189-330 |
| Product NUI | N0000175576 N0000175450 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20220912 |
| Report Date | 20220921 |
| Classification Date | 20220915 |
| Address | 94 Worldwide Dr Dawsonville, GA 30534-6828 United States |
| Recalling Firm | Direct Rx |
| Initial Notification | Letter |
| Unique Ingredient Identifier | F446C597KA |
| Drug Application Number | ANDA086413 |
| Structured Product Labeling (SPL ID) | d92e9eaf-3a7a-76d7-e053-2995a90ae28d |
| Structured Product Labeling (SPL Set ID) | d92e9eaf-3a79-76d7-e053-2995a90ae28d |
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