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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