FDA recall D-0637-2024

Teva Pharmaceuticals USA, Inc · Class II · 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

Reason for recall

Superpotent Drug

Distribution

Product was distributed nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2024-08-08
Report date: 2024-08-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0637-2024