Johnson & Johnson Recalls Duragesic Pain Patches

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Johnson Johnson Recalls Duragesic Patches Drug Toxic Chemicals

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Johnson & Johnson issued a voluntary recall all lots of its 25 microgram/hour (mcg/hr) DURAGESIC (fentanyl transdermal system) CII patches sold in the US by PriCara and all 25 mcg/hr fentanyl patches sold in the US by Sandoz Inc. The company reported that the patches may have a cut edge that could leak fentanyl gel and cause serious injury.
Details of the recall
According to a Johnson & Johnson press release – PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and a member of the Johnson & Johnson family of companies – the following products are being recalled:
All lots of 25 microgram/hour (mcg/hr) DURAGESIC (fentanyl transdermal system) CII patches sold by PriCara in the United States
All 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States
All of the recalled patches were manufactured by the ALZA Corporation, an affiliate of PriCara, and have expiration dates on or before December 2009. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled. Patches with 12.5, 50, 75 and 100 mcg/hr strengths aren’t affected.
Safety warnings
The patches may have a cut along one side of the drug reservoir within the patch that may result in the possible release of fentanyl gel and may expose patients or caregivers to that gel – an opioid analgesic with a potency approximately 80 times that of morphine or greater. Patches that are cut or damaged should not be used as serious injury could occur. According to the company:
Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.
Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.
Additional information
Johnson & Johnson provided the following consumer information:
Anyone with 25 mcg/hr DURAGESIC patches being recalled should call 800-547-6446.
Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call800-901-7236.
Patients using fentanyl patches who have medical questions should contact their health-care providers.