SUN PHARMACEUTICAL INDUSTRIES INC recalls Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited,
Recalled March 29, 2023 · FDA recall D-0474-2023 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Failed Content Uniformity Specifications · FDA Class III
Units
1,920 bottles
Sold at
USA nationwide.
Description
Failed Content Uniformity Specifications
Product
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →