Drug Enforcement D-0390-2024

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

Status

Ongoing

Classification

Class II

Report Date

March 27, 2024

Termination Date

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Product Information

Product 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
Product quantity
335,940 vials
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0390-2024
Event ID
94073
Recall initiation date
February 20, 2024
Center classification date
March 19, 2024
Code info
Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
More code info
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