FDA recall D-0127-2024

Teva Pharmaceuticals USA, Inc · Class III · drug

Product

Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30

Reason for recall

OOS for viscosity

Distribution

USA nationwide

Key facts

Status
Terminated
Initiation date
2023-11-10
Report date
2023-12-06
Termination date
2024-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2024