Class II · Moderate risk Ongoing
fentaNYL Citrate
Reason Subpotent Drug
Actiq
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specification; during stability testing
What 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
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- NDC code
- 63459-502-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-606-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Fentanyl recalls
See all
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
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