FDA recall D-0391-2024

Eugia US LLC · Class II · drug

Product

Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11

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-0391-2024