FDA-Drug2018-02-14Class III
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), 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 0591-3212-54.
Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Sold states
Distributed nationwide within the United States
Affected count
929,916 (5 pouches/carton)
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), 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 0591-3212-54.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0541-2018Don't want to check this manually?
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