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Fentanyl 25 mcg/hr Patch from Actavis - Recall
Actavis, in cooperation with FDA, has issued a voluntary recall of several lot numbers of fentanyl 25 mcg/hr patches. The fentanyl 25 mcg/hr patches are being recalled due to faster release of product found during testing of one lot of fentanyl. Faster release of fentanyl can cause increased somnolence and affect the ability to breathe. No adverse events have been reported due to this defect at this time. Several lots are being recalled preventively. A list of affected lots can be found through the MedWatch link below.
All affected lots should be returned to Actavis. For questions regarding the recall and reimbursement customers can call Actavis at 1-888-896-4562. For questions regarding adverse reactions and for other medical question regarding the fentanyl patches, consumers and healthcare professionals can call Actavis at 1-877-422-7452.
Additional information can be found at the following links:
- MedWatch Report:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230639.htm - FDA Press Release:
http://www.fda.gov/Safety/Recalls/ucm230498.htm
Updated
October 22, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
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