TRIAMCINOLONE ACETONIDE Recall D-1106-2022
Description: Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15
TRIAMCINOLONE ACETONIDE Recall D-1106-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1106-2022 |
| Event ID | 89646 |
| Brand | TRIAMCINOLONE ACETONIDE |
| Generic Name | TRIAMCINOLONE ACETONIDE |
| Manufacturer | TRIAMCINOLONE ACETONIDE |
| Original Package? | 1 |
| Active Substance | TRIAMCINOLONE ACETONIDE |
| Drug Route | TOPICAL |
| Distribution | USA nationwide. |
| Quantity | 30 tubes |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0168-0002 0168-0003 0168-0004 |
| Product NUI | N0000175576 N0000175450 |
| Drug UPC | 0301680003153 0301680002156 0301680004150 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | F446C597KA |
| Drug Application Number | ANDA085692 |
| Structured Product Labeling (SPL ID) | 719f34d8-deb8-446f-a201-3f74fed4e831 |
| Structured Product Labeling (SPL Set ID) | 92a1ded0-8e1a-4994-9c8a-89e84fc85c94 |
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