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
Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).
What was recalled
Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60
- Recalling firm
- Pfizer Inc.
- NDC code
- 00069-5820-60
- Origin
- N/A
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1253-2014
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.
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