Recall: D-0443-2024

Class III - Minor Violations

Class IIIClassification

2024-03-25Initiated

TerminatedStatus

Novitium Pharma LLCFirm

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

Reason

Failed Impurities/Degradation Specifications

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.