Class III · Low risk Terminated
Dofetilide Capsules 500 mcg
Reason Out of Specification result observed in content uniformity testing
Tikosyn
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
What was recalled
Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.
- Recalling firm
- Pfizer Inc.
- NDC code
- 0069-5800-61
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0292-2015
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 Dofetilide recalls
See all
Class III · Low risk Terminated
Dofetilide Capsules
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
Dofetilide Capsules 500 mcg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Dofetilide Capsules 250 mcg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Dofetilide Capsules
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.