Drug Enforcement D-1082-2023

Out of Specification result observed in content uniformity testing

Status

Terminated

Classification

Class III

Report Date

August 16, 2023

Termination Date

February 26, 2024

Product Information

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
Product quantity
360 60-count bottles
Reason for recall
Out of Specification result observed in content uniformity testing
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1082-2023
Event ID
92725
Recall initiation date
July 18, 2023
Center classification date
August 7, 2023
Code info
Lot: DNE0217A, Exp 01/2025
More code info
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