July 2023 FDA Recall Dofetilide by Sun Pharmaceutical Industries Inc
D-1082-2023 - Out of Specification result observed in content uniformity testing
This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on July 18, 2023 for the product Dofetilide. The FDA reported the reason for recall as out of specification result observed in content uniformity testing. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1082-2023
Out of Specification result observed in content uniformity testing
07-18-2023
08-16-2023
360 60-count bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
02-26-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
