TRIAMCINOLONE ACETONIDE Recall D-0696-2022
Description: Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.
TRIAMCINOLONE ACETONIDE Recall D-0696-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0696-2022 |
| Event ID | 89798 |
| 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 and Puerto Rico |
| Quantity | 159,994 tubes |
| Recall Reason | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| Drug Classification | Class II |
| Drug Code Info | 20220330 |
| Product NDC | 52565-048 |
| Product NUI | N0000175576 N0000175450 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20220315 |
| Report Date | 20220330 |
| Classification Date | 20220321 |
| Address | 105 Lincoln Avenue Buena, NJ 08310 United States |
| Recalling Firm | Teligent Pharma, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | F446C597KA |
| Drug Application Number | ANDA208590 |
| Structured Product Labeling (SPL ID) | a6cb1ad5-f103-47f6-9dea-72b8432ef3e9 |
| Structured Product Labeling (SPL Set ID) | 76d9b45a-9efd-efa3-00ad-d32a24ef0ff8 |
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