Reported Jun 19, 2013 · Terminated

Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC…

Actavis

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Actavis · 575/577/579 Chipeta Way · Salt Lake City, UT · 84108-1222

Is this the product you have?

  • 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 byWatson Pharma, Inc
Lot codes and dates
    • Lot #: Patch 453658
    • Carton 453658A
    • Exp 09/13
Amount recalled
98,952 boxes

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 9, 2014 · Data as of Sep 19, 7:55 PM UTC

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