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Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h
Date:10/21/2010

Corium, a third party supplier for Actavis, manufactured the recalled patches at their Grand Rapids, Michigan facility.

Under this recall, all wholesalers and retailers are being asked to return the product they have on hand or in stock. Fentanyl patches sold by Actavis in Europe are not impacted in this recall.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Information also is available through the Actavis U.S. website at www.actavis.us by going to the "Fentanyl Recall Information" link on the front page.

Actavis has operators available to help customers, health professionals and consumers with the following information:

  • Medical Issue/Adverse Event/Product Questions: 1-877-422-7452 (24 hours/day, 7 days/week)

  • Return/Reimbursement Questions: 1-888-896-4562 (24 hours/day, 7 days/week)

  • Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Online:www.fda.gov/medwatch/report.htm

    Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

    Fax: 1-800-FDA-0178

    About Actavis Inc.Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one quarter of Actavis' sales are generated in North America, Actavis' single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing facilities in Elizabeth, NJ and Lincolnton, NC. Actavis also has research and development facilities in Sunrise, FL and Owings Mills, MD. For more information, please visit www.actavis.us.

    About Actavis Group
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