Recalling firm
Eugia US LLC
Product type
Drug
Status
Ongoing
Report date
2024-03-27
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
43,920 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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
Code / lot info
Lot #: 3NC22019, Exp. Date 2/24
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.