Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches
February 15, 2008
PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation.
Popularity: 62% [?]
Duragesic Recalled
February 15, 2008
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.
Popularity: 58% [?]
