NICARDIPINE HYDROCHLORIDE Recall D-0391-2024
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
NICARDIPINE HYDROCHLORIDE Recall D-0391-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0391-2024 |
Event ID | 94073 |
Brand | NICARDIPINE HYDROCHLORIDE |
Generic Name | NICARDIPINE HYDROCHLORIDE |
Manufacturer | NICARDIPINE HYDROCHLORIDE |
Original Package? | 1 |
Active Substance | NICARDIPINE HYDROCHLORIDE |
Drug Route | INTRAVENOUS |
Distribution | Nationwide within the United States |
Quantity | 43,920 vials |
Recall Reason | Failed Impurities/Degradation Specifications: Out of specification for organic impurities |
Drug Classification | Class II |
Drug Code Info | 20240327 |
Product NDC | 55150-183 |
Drug UPC | 0355150183029 |
Recall Initiation Date | 20240220 |
Report Date | 20240327 |
Classification Date | 20240319 |
Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
Recalling Firm | Eugia US LLC |
Initial Notification | Letter |
Unique Ingredient Identifier | K5BC5011K3 |
Drug Application Number | ANDA211121 |
Structured Product Labeling (SPL ID) | 9f5d3050-9cdf-404f-ac0f-72399178959f |
Structured Product Labeling (SPL Set ID) | 9f5d3050-9cdf-404f-ac0f-72399178959f |
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