The patches affected come in 25 microgram-per-hour doses, with an expiration date on or before December of 2009.
Johnson & Johnson says manufacturing issues could lead to accidental overdoses of the opioid fentanyl. 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.
In December, the FDA put out its second warning in two years about the dangers of misusing the powerful drug.
The drug is intended for chronic pain in people used to narcotics, such as cancer patients, and can cause trouble breathing in people not used to this family of painkillers. Yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain. 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.
All of the patches were manufactured by PriCara affiliate ALZA Corp. PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
The Associated Press contributed to this report.