FDA-Drug2024-03-27Class II
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
Eugia US LLC
Hazard
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Sold states
Nationwide within the United States
Affected count
335,940 vials
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0390-2024Don't want to check this manually?
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