FDA-Drug2024-03-27Class II
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
Eugia US LLC
Hazard
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Sold states
Nationwide within the United States
Affected count
43,920 vials
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief