← FDA ENFORCEMENT
D-0637-2024Class II

Teva Pharmaceuticals USA, Inc

Recalling firm
Teva Pharmaceuticals USA, Inc
Product type
Drug
Status
Ongoing
Report date
2024-08-28
Distribution
Product was distributed nationwide within the United States
Firm state
NJ
Product quantity
7,080 unit dose packets
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Superpotent Drug

Product description

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

Code / lot info

Lot #: 100042386, Exp. Date 06/2025

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.