Eugia US LLC: Drug Recall

Recall #D-0391-2024 · 02/20/2024

Class II: Risk

Recall Details

Recall Number: D-0391-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Eugia US LLC
Status: Ongoing
Date Initiated: 02/20/2024
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 43,920 vials

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide within the United States

Other Recalls by Eugia US LLC

Class II: Risk 05/29/2025

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/10/2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II: Risk 12/27/2024

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

View all recalls by Eugia US LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.