FDA recall D-0389-2024

Novitium Pharma LLC · Class III · drug

Product

Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20

Reason for recall

Cross Contamination with Other Products:(mycophenolate mofetil).

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2024-03-04
Report date
2024-03-27
Termination date
2025-03-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2024