August 2024 FDA Recall Testosterone by Teva Pharmaceuticals Usa, Inc
D-0637-2024 - Superpotent Drug
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on August 8, 2024 for the product Testosterone. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0637-2024
Superpotent Drug
08-08-2024
08-28-2024
7,080 unit dose packets
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 100042386, Exp. Date 06/2025
