Patches containing the prescription painkiller fentanyl were recalled Tuesday, because of a flaw that could cause patients or caregivers to overdose on the potent drug inside.
Sold in the United States under the brand name Duragesic by PriCara and generically by Sandoz Inc., the recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009.
Some of the patches may have a cut in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks into the drug's packaging, it could cause a patient or caregiver to come into direct contact with this powerful "opioid" drug. This could result in difficulty breathing and a potentially fatal overdose.
If this reservoir is cut, it can be seen when the foil pouch containing an individual patch is opened. Damaged patches should be flushed down the toilet and not handled. Skin that has been exposed to the gel should be thoroughly rinsed with water, but not washed with soap.
PriCara estimates that two patches out of every million included in the recall have the defect that causes the leak.
For details on Duragesic patches sold by PriCara, call 800-547-6446. For details on generic fentanyl patches sold by Sandoz, call 800-901-7236.
The recalled patches were also sold in Canada under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd.