Another company has recalled Fentanyl patches due to the same defect causing leakage. Heck of a drug to have shoddy manufacturing practices considering direct application to the skin of what's in the patch can be FATAL! Patty
February 19, 2008 — A voluntary nationwide recall has been issued for 14 lots of Actavis generic fentanyl CII transdermal systems because of a potential fold-over defect, the US Food and Drug Administration (FDA) announced today. The resulting leakage can result in patient and/or caregiver exposure to fentanyl gel, according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting program. Adverse events associated with such direct exposure may include respiratory depression and potentially fatal overdose.
The recall follows on the heels of a recall last week by PriCara and Sandoz of all lots of 25-μg/hour fentanyl transdermal systems because of a cut along one side of the drug reservoir, which could also potentially expose patients and/or caregivers to fentanyl gel.
According to a company news release, Actavis is unaware of any injuries resulting from this issue; the recall is a precautionary measure only. Fentanyl patches sold by the company in Europe are not affected by the action.
Affected patches are made by Corium International, Inc (a contract manufacturer for Actavis Group HF) and sold by Actavis' subsidiary, Actavis South Atlantic LLC (formerly Abrika Pharmaceuticals, Inc). Pouches containing the patch are labeled with the Abrika name, but the outer carton bears the Actavis logo.
Recalled lots covered cover the 25-, 50-, 75-, and 100-µg/hour strengths. Specific lot numbers include 27261 (expiration date 5/09), 27317 (expiration date 5/09), 27318 (expiration date 6/09), 27319 (expiration date 6/09), 27391 (expiration date 6/09), 27409 (expiration date 6/09), 27475 (expiration date 7/09), 27476 (expiration date 6/09), 27488 (expiration date 6/09), 27514 (expiration date 7/09), 27536 (expiration date 7/09), 27537 (expiration date 8/09), 27538 (expiration date 8/09), and 27545 (expiration date 7/09).
Consumers in possession of recalled fentanyl patches are instructed to contact the company at 1-877-422-7452.
Damaged and/or compromised patches should be immediately flushed down the toilet; skin exposed to fentanyl gel must be rinsed with large amounts of water, but no soap.
Fentanyl transdermal systems are indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and that cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids. The transdermal systems should be reserved for use in opioid-tolerant patients 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, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.