November 2020 FDA Recall Testosterone by Teva Pharmaceuticals Usa
D-0100-2021 - Superpotent Drug
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on November 11, 2020 for the product Testosterone. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0100-2021
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
11-11-2020
11-25-2020
12,088 cartons
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
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 in the USA.
06-24-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
Batch or Lot Expiration Information
Lot# Lot Number: 1351104, Exp 08/2021
