Class III · Low risk
Dofetilide Capsules 500 mcg
Out of Specification result observed in content uniformity testing
Tikosyn¿ (dofetilide)
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).
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
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
Affected NDC
0069-5820-60
Compare with the code on your package — it is the most precise check available.
Drug: Dofetilide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tikosyn dofetilide NDC 00069-5820 |
.5 mg/1 | Capsule Oral |
Pfizer Laboratories Div Pfizer Inc | Rx |
- Recalling firm
- Pfizer Inc.
- NDC code
- 00069-5820-60
- Origin
- N/A
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1253-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dofetilide recalls
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Class III · Low risk
Dofetilide Capsules
Failed Content Uniformity Specifications
Class II · Moderate risk
Dofetilide Capsules 500 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules 250 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules
CGMP Deviations: recalling drug products following an FDA inspection.
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