Accord Healthcare recalls Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottles manufactured for FDA compliance issues. Recalled batches expire through May 2025.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottles due to FDA inspection findings. This recall affects specific batches produced in India with expiration dates through May 2025. The product is prescription-only and requires medical supervision.
The recall follows FDA inspections that found manufacturing process deviations. While the exact hazard isn't specified, these deviations could potentially affect drug quality or safety. The product is prescription-only and requires medical supervision.
Prescription patients who have received Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottles from the recalled batches. Patients with heart conditions requiring this medication are most at risk.
Check for the product name 'Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle' with the manufacturer 'Accord Healthcare, Inc.' on the label. Look for specific batch numbers and expiration dates listed in the recall notice.
Identify the batch number and expiration date on the capsule bottle label.
The FDA found manufacturing process deviations during an inspection, requiring this recall.
The recall indicates potential quality issues, but the product is prescription-only and requires medical supervision.
Check the batch number and expiration date on the label to see if it's in the recalled batches.
Look for specific batch numbers and expiration dates listed in the recall notice.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0384-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0384-2023 from Accord Healthcare. 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.
