D-0127-2024 Class III Terminated

Recalled by Teva Pharmaceuticals USA, Inc — Parsippany, NJ

FDA drug recall D-0127-2024 was initiated by Teva Pharmaceuticals USA, Inc on November 10, 2023 and is designated Class III. Reason for recall: OOS for viscosity The recall status is terminated (terminated June 3, 2024).

Recall Details

Product Type
Drugs
Report Date
December 6, 2023
Initiation Date
November 10, 2023
Termination Date
June 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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 Pattern

USA nationwide

Code Information

Lot #: 100029472, Exp. 2/29/2024