Fentanyl Gel Patches Recalled Due to Manufacturing Defect

A nationwide recall has been issued for all lots of 25-μg/hour fentanyl transdermal systems (Duragesic, PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc) and generics made by Sandoz, Inc) due to manufacturing defects, the US Food and Drug Administration announced on Friday.

Some patches may have a cut along one side of the drug reservoir, potentially exposing patients and/or caregivers to fentanyl gel that could leak into the foil packaging. Adverse events associated with such direct exposure may include respiratory depression and potentially fatal overdose, according to an alert issued by MedWatch, the FDA’s safety information and adverse event reporting program.

Affected patches have expiration dates of December 2009 or earlier printed on the foil pouch/box. Patches with a cut reservoir can be identified when the foil is opened, and should not be used or handled directly; damaged items should be immediately flushed down the toilet. Skin exposed to fentanyl gel must be rinsed with large amounts of water, but no soap.

More information regarding recalled brand-name patches sold by PriCara may be obtained by calling 1-800-547-6446; more information regarding the recalled generic formulation is available from Sandoz at 1-800-901-7236. All patches were manufactured by PriCara affiliate Alza Corp; those made by Alza for sale in Canada are also being recalled.

Fentanyl transdermal systems are indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients aged 2 years and older who require a total opioid dose at least equivalent to a 25-µg/hour patch.

According to a company news release, matrix-design fentanyl patches made by Mylan, Inc, are not involved in the recall.

Adverse events related to use of fentanyl patches should be reported to the FDA’s MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Yael Waknine is a freelance writer for Medscape