← FDA ENFORCEMENT
D-1082-2023Class III

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product type
Drug
Status
Terminated
Report date
2023-08-16
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
360 60-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Out of Specification result observed in content uniformity testing

Product description

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

Code / lot info

Lot: DNE0217A, Exp 01/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.