Actiq (oral transmucosal fentanyl citrate) 200 mcg recall: Failed Dissolution
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…
Why was Actiq (oral transmucosal fentanyl citrate) 200 mcg recalled?
Failed Dissolution Specification; during stability testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot C88583, exp. 06/15
- Product
- 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…
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Quantity
- 316 cartons
- Distribution
- Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
- Recall date
- June 26, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)