Sun Pharmaceutical Industries Inc. is recalling 1,920 bottles of Dofetilide (dofetilide) Capsules, 500 mcg (0.5 mg). This recall was initiated because the product failed testing for content uniformity, meaning some capsules may have inconsistent amounts of the active ingredient. The affected capsules were distributed in 60-count bottles through pharmacies nationwide.
Inconsistent amounts of medication in capsules can lead to patients receiving more or less than their prescribed dose, which could impact the effectiveness of the treatment or lead to unexpected side effects. No injuries or adverse events have been reported to date.
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Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India.
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Sources: FDA iRES · Raw API Response
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