Nicardipine Hydrochloride Injection, Solution
FDA Recall NDC 55150-183
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Nicardipine Hydrochloride (NDC 55150-183). A significant event, classified as Class II, was initiated on Feb 20, 2024 by Eugia Us Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification for organic impurities"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
February 2024 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Feb 20, 2024
Mar 27, 2024
335,940 vials
Recall Profile & Regulatory Data
Event ID
94073
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
Affected Packages Involved in this Recall
55150-183-01Product
55150-183-10Product
February 2024 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Feb 20, 2024
Mar 27, 2024
43,920 vials
Recall Profile & Regulatory Data
Event ID
94073
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 3NC22019, Exp. Date 2/24
Affected Packages Involved in this Recall
55150-183-02Product
55150-183-11Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
