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February 21, 2008

Transdermal Fentanyl painkiller patches recalled by FDA

The FDA has announced a recall of a transdermal patch system, which contains the prescription painkiller Fentanyl. The patches are sold in the U.S. under the names, Duragesic by PriCara and a generic version by Sandoz Inc. In Canada, the recalled patches are sold under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd. The recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009. It has been discovered that some of the patches may have a cut in the lining of the internal reservoir where the drug is held in gel form. Fentanyl is a powerful “opiod” drug and if it leaks into the drug’s packaging, releasing into the skin it could cause difficulty breathing and a potentially fatal overdose. If skin has been exposed to an increased amount of the gel due to a cut in the reservoir the area should be thoroughly rinsed, but do not wash with soap.

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