March 2024 FDA Recall Digoxin by Novitium Pharma Llc
D-0443-2024 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Novitium Pharma Llc on March 25, 2024 for the product Digoxin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0443-2024
Failed Impurities/Degradation Specifications
03-25-2024
04-24-2024
1,003 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.
Novitium Pharma LLC
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.
U.S. Nationwide
07-16-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
Batch or Lot Expiration Information
Lot# Lot M23011A; Exp. 12/2024
