Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharm
Summary
The FDA issued a Class II for Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx by Eugia US LLC. Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities.
Details
Source
Drug Recall
External ID
D-0390-2024
Action Date
2024-03-27
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
Quantity Affected: 335,940 vials
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-20
Company
East Windsor, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eugia US LLC has 17 FDA actions in our database, including 17 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Eugia US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eugia US LLC have FDA actions?
Eugia US LLC has 17 FDA actions in our database, including 17 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0390-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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