SUN PHARMACEUTICAL INDUSTRIES INC recalls Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Su
Recalled August 16, 2023 · FDA recall D-1082-2023 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Out of Specification result observed in content uniformity testing · FDA Class III
Units
360 60-count bottles
Sold at
Nationwide in the USA
Description
Out of Specification result observed in content uniformity testing
Product
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →