March 2023 FDA Recall Drug by Sun Pharmaceutical Industries Inc
D-0474-2023 - Failed Content Uniformity Specifications

This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on March 9, 2023 for the product Drug. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0474-2023

Reason for Recall
Failed Content Uniformity Specifications
Initiated
03-09-2023
Reported
03-29-2023
Quantity
1,920 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91871
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# DND1541A, Exp 08/2024