Sun Pharmaceutical recalls 500 mcg Dofet: 60-count bottles due to content uniformity testing failures. This may affect medication accuracy. Contact for return instructions.
Out of Specification result observed in content uniformity testing
Sun Pharmaceutical is recalling 500 mcg Dofetilide capsules (60-count bottles) because testing showed inconsistent medication content. This could lead to incorrect dosing if the capsules don't contain the right amount of active ingredient.
The capsules failed content uniformity testing, meaning the actual medication content may vary from the labeled amount. This could result in incorrect dosing if the capsules don't contain the intended 500 mcg of active ingredient.
Prescription patients using the recalled capsules. Those with specific medical conditions requiring precise dosing may be at slightly higher risk.
Check for the 60-count bottle labeled 'Dofetilide Capsules 500 mcg (0.5mg), Rx Only'. The NDC code is 47335-063-86 and lot number DNE0217A, expiring January 2025.
Look for the NDC code 47335-063-86 and lot number DNE0217A on the bottle.
The capsules failed content uniformity testing, which means the actual medication content may vary from the labeled amount.
Check for the NDC code 47335-063-86 and lot number DNE0217A on the bottle.
The recall record does not specify a remedy, so contact Sun Pharmaceutical for guidance.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-1082-2023 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-1082-2023 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
