RecallDepth
Class II Ongoing

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

Company
Eugia Us Llc
Recall Initiated
February 20, 2024
Posted
March 27, 2024
Recall Number
D-0390-2024
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
335,940 vials
Firm Location
East Windsor, NJ, United States

Reason for Recall

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Distribution

Nationwide within the United States

Lot / Code Info

Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24

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