Recall Enforment Report D-0235-2022

Drug Recall Enforcement Report Class III voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 10-28-2021 for 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 The product was recalled due to failed impurities/degradation specifications. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88938 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0235-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description 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
Reason For Recall Failed Impurities/Degradation Specifications What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 64,978 patches Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 11-24-2021
Recall Initiation Date 10-28-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Teva Pharmaceuticals USA
Code Info Lot# 1369117B, exp. date 11/2021 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 0591-3508-54; 0591-3508-04; 0591-3509-54; 0591-3509-04; 0591-3510-54; 0591-3510-04
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0591-3508Clonidine Transdermal System ClonidinePatchTransdermalActavis Pharma, Inc.Human Prescription Drug
0591-3509Clonidine Transdermal System ClonidinePatchTransdermalActavis Pharma, Inc.Human Prescription Drug
0591-3510Clonidine Transdermal System ClonidinePatchTransdermalActavis Pharma, Inc.Human Prescription Drug