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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot C88583, exp. 06/15
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teva Pharmaceuticals USA, Inc.
- Reason for Recall:
- Failed Dissolution Specification; during stability testing
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot C88583, exp. 06/15
Distribution:
Distributed in: FL, IL, MA, MO, MS, OH, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-606-2013
Related Recalls
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CGMP Deviations: use of an unapproved raw material