Eugia US LLC recalls Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Prin
Recalled March 27, 2024 · FDA recall D-0391-2024 · Eugia US
Hazard
Failed Impurities/Degradation Specifications: Out of specification for organic impurities · FDA Class II
Units
43,920 vials
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
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
Manufacturer(s)
Eugia US LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →