TESTOSTERONE Recall D-1289-2022
Description: Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
TESTOSTERONE Recall D-1289-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1289-2022 |
Event ID | 90534 |
Brand | TESTOSTERONE |
Generic Name | TESTOSTERONE |
Manufacturer | TESTOSTERONE |
Original Package? | 1 |
Active Substance | TESTOSTERONE |
Drug Route | TOPICAL |
Distribution | Nationwide in the USA |
Quantity | 12354 cartons |
Recall Reason | Superpotent Drug: Out of specification assay result was obtained during stability testing. |
Drug Classification | Class II |
Drug Code Info | 20220803 |
Product NDC | 0591-2921 0591-3216 0591-3217 |
Product NUI | N0000175824 N0000000146 M0001109 |
Pharma Class (EPC) | Androgen [EPC] |
Pharma Class (CS) | Androstanes [CS] |
Recall Initiation Date | 20220629 |
Report Date | 20220803 |
Classification Date | 20220725 |
Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
Recalling Firm | Teva Pharmaceuticals USA Inc |
Unique Ingredient Identifier | 3XMK78S47O |
Drug Application Number | ANDA076737 |
Structured Product Labeling (SPL ID) | 675e27bc-c538-40c8-bfb5-7ed1656c3d02 |
Structured Product Labeling (SPL Set ID) | 5834d34f-839d-412c-b74c-da1dad2cfa88 |
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