FDAFDA · Food and drugs·Recall number D-606-2013
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 by: Cephalon, Inc., Salt Lake City, UT 84116
Published June 26, 2013 · Recall initiated: May 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification; during stability testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Distributor
- Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
- Lot
- Lot C88583, exp. 06/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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