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Teva Pharmaceuticals USA recalls Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis

Recalled February 14, 2018 · FDA recall D-0542-2018 · Teva Pharmaceuticals USA

Hazard
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits · FDA Class III
Units
576, 760 (5 pouches/carton)
Sold at
Distributed nationwide within the United States

Description

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Product
Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), 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 0591-3213-54.
Manufacturer(s)
Teva Pharmaceuticals USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Teva Pharmaceuticals USA recalls Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis | RecallWatchUSA