FDA recall D-0443-2024

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 for recall

Failed Impurities/Degradation Specifications

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2024-03-25

Report date

2024-04-24

Termination date

2024-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

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