Teva Pharmaceuticals USA recalls Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by:…

Recall date

January 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0541-2018

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Distributed nationwide within the United States

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.