Why it was recalled
Failed Dissolution Specification; during stability testing
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
Lot numbers, UPCs & expiration codes
Lot C88583, exp. 06/15
Where it was sold
Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-606-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 28, 2013
- FDA report date
- Jun 26, 2013
- Quantity
- 316 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-606-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 65298
- Address
- 650 Cathill Rd
- Code information
- Lot C88583, exp. 06/15
- Postal code
- 18960-1512
- Report date
- Jun 26, 2013
- Product type
- Drugs
- Recall number
- D-606-2013
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 316 cartons
- Termination date
- Jul 23, 2014
- Reason for recall
- Failed Dissolution Specification; during stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
- Recall initiation date
- May 28, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 19, 2013