Reported Jun 26, 2013 · Terminated

Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30…

Teva Pharmaceuticals USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Teva Pharmaceuticals USA, Inc. · 650 Cathill Rd · Sellersville, PA · 18960-1512

Is this the product you have?

  • Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only
  • Manufactured byCephalon, Inc., Salt Lake City, UT 84116
Lot codes and dates
    • Lot C88583
    • exp. 06/15
Amount recalled
316 cartons

Where it was sold

Why it was recalled

Failed Dissolution Specification; during stability testing

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 23, 2014 · Data as of Sep 19, 7:53 PM UTC

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