Recall: D-0391-2024

Class II - Potentially Harmful

Class IIClassification

2024-02-20Initiated

OngoingStatus

Eugia US LLCFirm

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

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.