Class III · Low risk
Dofetilide Capsules 500 mcg
Out of Specification result observed in content uniformity testing
Dofetilide Capsules 250 mcg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9
Affected NDC
16729-0491-12
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 |
|---|---|---|---|---|
| Dofetilide NDC 16729-0491 |
.25 mg/1 | Capsule Oral |
Accord Healthcare, Inc. | Rx |
- Recalling firm
- Accord Healthcare, Inc.
- NDC code
- 16729-491-12
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0384-2023 · 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.
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Class II · Moderate risk
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