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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Actavis Encourages Consumers to Return Fentanyl Transdermal System 25 mcg/h

Operators available to handle voluntary recall of 18 lots

Company Contact: 
Media Line 
Actavis U.S.
973-889-6689

Email: media@actavis.com

 

FOR IMMEDIATE RELEASE – November 4, 2010 – Morristown, NJFurther to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to return any product in their possession from the October 21, 2010 recall.

Consumers with Actavis 25 mcg/h Fentanyl patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions and information.

Actavis identified one lot of 25 mcg/hour Fentanyl patches (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient in laboratory testing faster than the approved specification. An accelerated release of Fentanyl from a 25 mcg/hour patch could lead to adverse events for at-risk patients such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

 

Recalled Control/Lot #s

30041, Exp 12/2011
30049, Exp 12/2011
30066, Exp 12/2011
30096, Exp 01/2012
30097, Exp 02/2012
30123, Exp 01/2012
30241, Exp 02/2012
30256, Exp 02/2012
30257, Exp 03/2012
30258, Exp 03/2012
30349, Exp 03/2012
30350, Exp 03/2012
30391, Exp 03/2012
30392, Exp 04/2012
30429, Exp 04/2012
30430, Exp 04/2012
30431, Exp 04/2012
30517, Exp 04/2012

 

Corium International Inc., a third-party supplier for Actavis, manufactured the recalled patches at its Grand Rapids, Michigan facility. The patches are packaged individually and boxed in quantities of five patches per box.

Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid 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

 

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