Accord Healthcare recalls 60-count Dofetilide Capsules (125 mcg) manufactured for FDA inspection deviations. This prescription-only medication may pose risks if not handled properly.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 60-count Dofetilide Capsules (125 mcg) due to FDA inspection findings. This prescription-only medication was produced in batches with specific expiration dates and may pose risks if not handled properly.
The recall is due to FDA inspection findings indicating deviations in current Good Manufacturing Practices (CGMP). This means the medication may not meet safety and quality standards, potentially leading to risks if used improperly.
Prescription patients who have the recalled Dofetilide Capsules (125 mcg, 60-count) from specific batches. Those with a prescription for this medication are most at risk.
Check for the product name 'Dofetilide Capsules', 125 mcg (0.125 mg), 60-count bottle, prescription-only. Look for batch numbers P2101480 through P2205412 with specific expiration dates.
Review the batch number and expiration date on the product label to confirm if it is part of the recalled batches.
The recall is due to FDA inspection findings indicating deviations in current Good Manufacturing Practices (CGMP).
Batches P2101480 through P2205412 with specific expiration dates as listed in the recall notice.
The recall does not specify a stop-use instruction; check the batch number and expiration date to determine if it is affected.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0383-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0383-2023 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.
