Johnson & Johnson unit recall

Johnson & Johnson’s PriCara unit recalled all lots of 25-microgram-per-hour Duragesic CII pain patches that may have a cut edge that could leak fentanyl gel.

The recalled patches, manufactured by Alza Corp. and sold by PriCara and Sandoz Inc. in the U.S. and Canada, have expiration dates on or before December 2009. Patches with 12.5, 50, 75 and 100 mcg/hr strengths aren’t affected.

PriCara said it is conducting the voluntary recall in cooperation with the Food and Drug Administration.

PriCara said patches with a cut edge that have leaked gel may lead to serious adverse events including respiratory depression and possible overdose.

A PriCara spokesman said there are six confirmed reports of defective patches and about 20 patches have been returned to the company.

The spokesman said there are about 80 lots out in the U.S. and 15 lots out in Canada. A lot is composed of 400,000 units. The spokesman said the estimated defect rate is about 2 per million.

The spokesman said the company doesn’t have any financial information on the impact of the recalls at this time.