TRIAMCINOLONE ACETONIDE Recall D-1497-2022
Description: Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
TRIAMCINOLONE ACETONIDE Recall D-1497-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1497-2022 |
| Event ID | 90790 |
| Brand | TRIAMCINOLONE ACETONIDE |
| Generic Name | TRIAMCINOLONE ACETONIDE |
| Manufacturer | TRIAMCINOLONE ACETONIDE |
| Original Package? | 1 |
| Active Substance | TRIAMCINOLONE ACETONIDE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA |
| Quantity | 57,816 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 | 20220907 |
| Product NDC | 45802-063 45802-064 45802-065 |
| Product NUI | N0000175576 N0000175450 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20220817 |
| Report Date | 20220907 |
| Classification Date | 20220907 |
| Address | 3940 Quebec Ave N Minneapolis, MN 55427-1244 United States |
| Recalling Firm | Padagis US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | F446C597KA |
| Drug Application Number | ANDA086413 |
| Structured Product Labeling (SPL ID) | 011704cc-50e1-42e1-9e4d-96d36b838c1f |
| Structured Product Labeling (SPL Set ID) | 5d2fe6c2-3856-47f6-843f-077b2e1080a0 |
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