Eugia US LLC recalls Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharm
Recalled March 27, 2024 · FDA recall D-0390-2024 · Eugia US
Hazard
Failed Impurities/Degradation Specifications: Out of specification for organic impurities · FDA Class II
Units
335,940 vials
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
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
Manufacturer(s)
Eugia US LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →