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Actavis Encourages Consumers to Return Fentanyl Transdermal System 25 mcg/h
Date:11/3/2010

oid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

As part of the voluntary recall, all wholesalers and retailers were asked to return the product from the listed lots that they may still have on hand or in stock. Actavis also is encouraging consumers to return product in their possession. Fentanyl patches sold by Actavis in Europe are not impacted by the 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 consumers, customers and health professionals 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 fac
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SOURCE Actavis Inc.
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