TESTOSTERONE Recall D-0637-2024
Description: Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
TESTOSTERONE Recall D-0637-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0637-2024 |
| Event ID | 95122 |
| Brand | TESTOSTERONE |
| Generic Name | TESTOSTERONE |
| Manufacturer | TESTOSTERONE |
| Original Package? | 1 |
| Active Substance | TESTOSTERONE |
| Drug Route | TRANSDERMAL |
| Distribution | Product was distributed nationwide within the United States |
| Quantity | 7,080 unit dose packets |
| Recall Reason | Superpotent Drug |
| Drug Classification | Class II |
| Drug Code Info | 20240828 |
| Product NDC | 0591-2924 0591-2925 0591-2926 |
| Product NUI | N0000175824 N0000000146 M0001109 |
| Pharma Class (EPC) | Androgen [EPC] |
| Pharma Class (CS) | Androstanes [CS] |
| Recall Initiation Date | 20240808 |
| Report Date | 20240828 |
| Classification Date | 20240816 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA, Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3XMK78S47O |
| Drug Application Number | ANDA204570 |
| Structured Product Labeling (SPL ID) | 1fffebb2-aabf-4d05-b9c0-5ce61b4cb345 |
| Structured Product Labeling (SPL Set ID) | 4f3c2c0a-7dab-4b50-9cae-869c3c2a8498 |
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