FDA-Drug2024-04-24Class III

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

Novitium Pharma LLC
Hazard

Failed Impurities/Degradation Specifications

Sold states
U.S. Nationwide
Affected count
1,003 bottles
Manufactured in
70 Lake Dr, East Windsor, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0443-2024

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