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
Recall Number: D-0391-2024
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, 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