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Actavis Inc. Recalls Fentanyl Patches as Safety Precaution
Products May Release Medication Too Quickly
By News Staff
Fentanyl patches are indicated for the management of moderate to severe chronic pain that requires around-the-clock opioid administration for an extended period of time and cannot be managed by other means, the agency said.
Actavis said in an Oct. 21 news release that it was unaware of any injuries associated with the affected patches, but the company recalled the product as a precaution. The recalled lot numbers are listed in the news release.
The voluntary recall is to the wholesale and retail levels only.
The recalled patches were manufactured for Actavis by Corium International at its Grand Rapids, Mich., facility. Corium also manufactured fentanyl patches sold under the Actavis brand that were recalled in 2008 because of a leakage problem that posed the danger of potential overdose.
Health professionals and consumers with questions about returning recalled product may call GENCO Pharmaceutical Services, which is handling the returns process for Actavis, at (888) 896-4562. Basic information about GENCO's return policies (13-page PDF; About PDFs) is available from the firm's website.
Physicians and consumers should report adverse reactions or quality problems associated with the patches to the FDA's MedWatch program.
Actavis Inc. U.S.: Fentanyl Recall Information