Dofetilide Capsule
FDA Recall NDC 47335-062
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dofetilide (NDC 47335-062). A significant event, classified as Class III, was initiated on Jul 18, 2023 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Out of Specification result observed in content uniformity testing"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
July 2023 Class III Recall: Out of Specification result observed in content uniformity testing
Recall Number
Class III Terminated
Out of Specification result observed in content uniformity testing
Jul 18, 2023
Aug 16, 2023
360 60-count bottles
Recall Profile & Regulatory Data
Event ID
92725
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Feb 26, 2024
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
Batch or Lot Expiration Information
Lot# Lot: DNE0217A, Exp 01/2025
Affected Packages Involved in this Recall
47335-061-86Product
47335-061-66Product
47335-061-79Product
47335-062-86Product
47335-062-66Product
47335-062-79Product
47335-063-86Product
47335-063-66Product
47335-063-79Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
