7 FDA recalls mention Dofetilide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dofetilide.
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 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.
Reason Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg…
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