November 2023 FDA Recall Testosterone by Teva Pharmaceuticals Usa, Inc
D-0127-2024 - OOS for viscosity
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on November 10, 2023 for the product Testosterone. The FDA reported the reason for recall as oos for viscosity. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0127-2024
OOS for viscosity
11-10-2023
12-06-2023
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide
06-03-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 100029472, Exp. 2/29/2024
