FDA-Drug2013-06-19Class III

Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.

Actavis
Hazard

Failed Impurities/Degradation Specifications

Sold states
Nationwide
Affected count
98,952 boxes
Manufactured in
575/577/579 Chipeta Way, N/A, Salt Lake City, UT, United States
Products
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-599-2013

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