Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity
Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with out-of-specification content uniformity testing results and no reported illnesses or deaths. Per the rubric, FDA Class III recalls are typically scored 1 or 2. The specification failure in the active pharmaceutical ingredient justifies a Moderate rating as a precautionary quality assurance recall.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Dofetilide 500 mcg capsules, a prescription antiarrhythmic medication. The recall affects 360 60-count bottles distributed nationwide in the USA. The affected lot is DNE0217A with expiration 01/2025.
The recall was initiated due to out-of-specification results observed in content uniformity testing. This means testing found that the active ingredient content did not meet FDA specifications for uniformity across the batch.
Patients and healthcare providers who have bottles from lot DNE0217A should discontinue use and contact Sun Pharmaceutical Industries Inc (Cranbury, NJ 08512) for information about return or replacement. Patients should consult their healthcare provider before making any changes to their medication regimen.
The recalled product
- Product
- DOFETILIDE (DOFETILIDE)
- Brand
- DOFETILIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Antiarrhythmic
- Hazard
- content-uniformity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: DNE0217A
- Exp 01/2025
UPCs (2)
- 0347335062861
- 0347335061864
Distribution
Distributed nationwide across the United States.
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- ModeratePrescription Drug Dofetilide Recalled Due to Manufacturing Compliance Deviations
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