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FDARecalled Aug 16, 2023 · #D-1082-2023

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 ...

Hazard

Class III — low health risk

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Description

Out of Specification result observed in content uniformity testing Classification: Class III Distribution: Nationwide in the USA

Product details

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
Type
Drugs
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Model numbers
DNE0217A
UPCs