Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: recalling drug products following an FDA inspection.
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-492-12 UPC 3 16729 49212 6
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Out of Specification result observed in content uniformity testing
Reason Failed Content Uniformity Specifications
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
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