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Recall Observatory FDA recall evidence

Drug product

Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11

D-0391-2024

February 20, 2024

Class II

Product summary

Firm
Eugia US LLC
Event
Event 94073
Status
Ongoing
Classification
Class II
Quantity
43,920 vials
Official record key
drug-enforcement:D-0391-2024

Official wording

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

Code information: Lot #: 3NC22019, Exp. Date 2/24

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification