FDA recall D-0390-2024

Eugia US LLC · Class II · drug

Product

Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2024-02-20
Report date: 2024-03-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0390-2024