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NICARDIPINE HYDROCHLORIDE Recall D-0390-2024

Description: 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

NICARDIPINE HYDROCHLORIDE Recall D-0390-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0390-2024
Event ID94073
BrandNICARDIPINE HYDROCHLORIDE
Generic NameNICARDIPINE HYDROCHLORIDE
ManufacturerNICARDIPINE HYDROCHLORIDE
Original Package?1
Active SubstanceNICARDIPINE HYDROCHLORIDE
Drug RouteINTRAVENOUS
DistributionNationwide within the United States
Quantity335,940 vials
Recall ReasonFailed Impurities/Degradation Specifications: Out of specification for organic impurities
Drug ClassificationClass II
Drug Code Info20240327
Product NDC55150-183
Drug UPC0355150183012
Recall Initiation Date20240220
Report Date20240327
Classification Date20240319
Address279 Princeton Hightstown Rd
East Windsor, NJ 08520-1401
United States
Recalling FirmEugia US LLC
Initial Notification Letter
Unique Ingredient IdentifierK5BC5011K3
Drug Application NumberANDA211121
Structured Product Labeling (SPL ID)c5ead57c-6f9e-41f5-b9cc-04c4c3abbcc9
Structured Product Labeling (SPL Set ID)dcd7d173-4d8e-4282-9edf-817711340e43
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