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
Recall Number: D-0390-2024
Firm: Eugia US LLC
Classification: Class II
Status: Ongoing
Report Date: 20240327
Initiation Date: 20240220
Termination Date:
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Product Description
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