Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium ...
FDA Recall #D-0443-2024 — Class III — March 25, 2024
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications
Recalling Firm
Novitium Pharma LLC — East Windsor, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,003 bottles
Distribution
U.S. Nationwide
Code Information
Lot M23011A; Exp. 12/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated