Drug product
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
D-0637-2024
Product summary
- Event
- Event 95122
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,080 unit dose packets
- Official record key
drug-enforcement:D-0637-2024
Official wording
Reason: Superpotent Drug
Code information: Lot #: 100042386, Exp. Date 06/2025
Distribution pattern: Product was distributed nationwide within the United States
Derived failure modes
-
Potency or specification failure
Superpotent