Drug Enforcement D-0391-2024

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

Status

Ongoing

Classification

Class II

Report Date

March 27, 2024

Termination Date

—

Product Information

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
Product quantity
43,920 vials
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0391-2024
Event ID
94073
Recall initiation date
February 20, 2024
Center classification date
March 19, 2024
Code info
Lot #: 3NC22019, Exp. Date 2/24
More code info
—