Accord Healthcare recalls 500 mcg Dofetilide Capsules (Rx only) manufactured in India with FDA inspection deviations. Consumers should contact the manufacturer for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 500 mcg Dofetilide Capsules (60-count bottles) due to FDA inspection findings. This recall affects prescription-only medication made by Intas Pharmaceuticals in India. The recall is part of a CGMP deviation response from an FDA inspection.
The recall is triggered by FDA inspections finding deviations in current good manufacturing practices (CGMP). This means the medication may not be produced safely or consistently as required by the FDA. The exact risk to patients is not specified in the recall notice.
Prescription patients who have the specific 500 mcg Dofetilide Capsules bottles with the listed batch numbers and expiration dates. Patients using this medication for heart conditions are most at risk.
Check for the 500 mcg (0.5 mg) Dofetilide Capsules 60-count bottles with the following batch numbers: P2101582, P2101661, P2101482, P2101686, P2102581, P2102598, P2103623, P2103653, P2103670, P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, P2200797, P2200773, P2200831, P2201017, P2201081, P2201056, P2200819. The product expires between February 2023 and May 2025.
Identify the batch numbers and expiration dates on your Dofetilide Capsules bottle to confirm if it is recalled.
The recall is due to FDA inspections finding deviations in current good manufacturing practices (CGMP).
Check for the specific batch numbers and expiration dates listed in the recall notice.
Contact Accord Healthcare directly for instructions on what to do with the medication.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0385-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0385-2023 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.
