PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: April 24, 2024 Initiated: March 25, 2024 #D-0443-2024

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

Details

Recalling Firm
Novitium Pharma LLC
Units Affected
1,003 bottles
Distribution
U.S. Nationwide
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Novitium Pharma LLC. Units affected: 1,003 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on April 24, 2024. Severity: Low. Recall number: D-0443-2024.