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Patches containing the prescription painkiller fentanyl were recalled for the second time in a week Monday, because of a flaw that could cause patients or caregivers to overdose on the potent drug inside.
Sold in the United States by Actavis South Atlantic LLC, the newly recalled patches have both this name and the company’s former name, Abrika Pharmaceuticals Inc., on their packaging. The old name is on the pouches that contain the patches and the new name is on the outer carton.
Last Tuesday PriCara, a division of Johnson & Johnson, announced a recall of fentanyl patches manufactured by its affiliate ALZA Corp.
Monday’s recall includes 25-microgram-per-hour, 50-microgram-per-hour, 75 microgram-per-hour and 100 microgram-per-hour patches with expiration dates of May through August 2009.
Some of the patches may have a defect that can cause them to leak, putting patients and caregivers at risk of coming into direct contact with the powerful “opioid” drug inside. This could result in difficulty breathing and a potentially fatal overdose.
The company has not received any reports of injuries related to this defect.
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.
The recalled patches were manufactured for Actavis Inc. by Corium International Inc. Activis Inc. is a division of Actavis Group hf.

by AOL

WASHINGTON - 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.

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.

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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.

by MSN