October 2021 FDA Recall Clonidine Transdermal System by Teva Pharmaceuticals Usa
D-0235-2022 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on October 28, 2021 for the product Clonidine Transdermal System. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0235-2022
Failed Impurities/Degradation Specifications
10-28-2021
11-24-2021
64,978 patches
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.
Nationwide and Puerto Rico
02-27-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Batch or Lot Expiration Information
Lot# 1369117B, exp. date 11/2021
