Product: Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72),  Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.
Reason for recall: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Recall initiated: 20180129
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated