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Johnson & Johnson Recalls Duralgesic Pain Patches due to Potential Fatal Opiate Overdose

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For the second time in less than a year, Johnson & Johnson is recalling some of its pain patches due to problems that could cause users to overdose on fentanyl—a highly addictive opiate 80 times stronger than morphine. The pain patches contain this drug to treat serious chronic pain.

Fentanyl has been labeled a Class II subtance by the Drug Enforcement Administration for its high risks of abuse and fatal overdose.

The patches being recalled are the Duralgesic and Sandoz Inc. 50 mcg/hr fentanyl transdermal system patches. They were manufactured by ALZA Corporation of Mountain View, CA, an affiliate of PriCara (of Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson). PriCara’s press release reports that other patch strengths, such as 12.5, 25, 75 and 100 mcg/hr, are not damaged and may be used as directed.

The company has identified a condition in the manufacturing equipment that has since been corrected. The condition resulted in a cut-system defect in a small number of affected patches in the lots being recalled. (…) DURAGESIC 50 mcg/hr (fentanyl transdermal system) patches and Sandoz Inc. 50 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel.

DURAGESIC 50 mcg/hr patches being recalled: lot number 0817239.

Anyone with 50 mcg/hr DURAGESIC patches from this lot should call 800-547-6446.

The Sandoz Inc. 50 mcg/hr patches being recalled: lot number 0816851.

Anyone with 50 mcg/hr Sandoz Inc. patches from this lot should call 800-901-7236.

Exposure to the opiate gel can lead to serious conditions including respiratory depression and possible fatal overdose.

If you have either of the affected pain patches, please check the box or foil pouch to see if they come from the recalled lots. At the risk of serious health problems, do not touch patches with cut edges directly. If you accidentally come into contact with fentanyl gel, wash the exposed skin with lots of water only, since soap, alcohol, lotions, oils and other skin products may only increase the skin’s permeability. Please dispose of cut patches by flushing them down the toilet, being very careful not to touch them directly. According to PriCara, the defective patches will not provide effective pain relief, and only pose health risks.

Apparently, since 2005 the FDA has received hundreds of reports of death from Duragesic Pain Patch fentanyl overdose, but has refused to say how many.