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
Reported: June 26, 2013 Initiated: May 28, 2013 #D-606-2013
Product Description
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
Reason for Recall
Failed Dissolution Specification; during stability testing
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 316 cartons
- Distribution
- Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 316 cartons.
Why was this product recalled? ▼
Failed Dissolution Specification; during stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2013. Severity: Moderate. Recall number: D-606-2013.
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