Recall: D-0390-2024

Class II - Potentially Harmful

Class IIClassification

2024-02-20Initiated

OngoingStatus

Eugia US LLCFirm

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

Reason

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.