HEPARIN SODIUM Recall D-0649-2024
Description: Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
HEPARIN SODIUM Recall D-0649-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0649-2024 |
| Event ID | 95102 |
| Brand | HEPARIN SODIUM IN SODIUM CHLORIDE |
| Generic Name | HEPARIN SODIUM |
| Manufacturer | HEPARIN SODIUM |
| Original Package? | 1 |
| Active Substance | HEPARIN SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 44,208 containers |
| Recall Reason | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. |
| Drug Classification | Class I |
| Drug Code Info | 20240911 |
| Product NDC | 0338-0424 0338-0431 0338-0433 |
| Recall Initiation Date | 20240801 |
| Report Date | 20240911 |
| Classification Date | 20240830 |
| Address | 25212 W Il Route 120 Round Lake, IL 60073-9799 United States |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Unique Ingredient Identifier | ZZ45AB24CA |
| Drug Application Number | NDA018609 |
| Structured Product Labeling (SPL ID) | bb28db8c-fb49-4b3c-9472-b0c2296a6e7f |
| Structured Product Labeling (SPL Set ID) | 0d929726-76c3-48fc-b4e7-fd06409f9fb3 |
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