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Recall Observatory FDA recall evidence

Drug product

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

D-0390-2024

February 20, 2024

Class II

Product summary

Firm
Eugia US LLC
Event
Event 94073
Status
Ongoing
Classification
Class II
Quantity
335,940 vials
Official record key
drug-enforcement:D-0390-2024

Official wording

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

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

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification