Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited,
Summary
The FDA issued a Class III for Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Failed Content Uniformity Specifications.
Details
Source
Drug Recall
External ID
D-0474-2023
Action Date
2023-03-29
Status
Terminated
Category
drug
Product Description
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
Lot/Code Info: Lot # DND1541A, Exp 08/2024
Quantity Affected: 1,920 bottles
Reason for Recall
Failed Content Uniformity Specifications
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-09
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0474-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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