Novitium Pharma LLC: Drug Recall

Recall #D-0443-2024 · 03/25/2024

Class III: Low Risk

Recall Details

Recall Number
D-0443-2024
Classification
Class III
Product Type
Drug
Recalling Firm
Novitium Pharma LLC
Status
Terminated
Date Initiated
03/25/2024
Location
East Windsor, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,003 bottles

Reason for Recall

Failed Impurities/Degradation Specifications

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

Distribution Pattern

U.S. Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.