HEPARIN SODIUM Recall D-0435-2023
Description: Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01
HEPARIN SODIUM Recall D-0435-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0435-2023 |
| Event ID | 91789 |
| Brand | HEPARIN SODIUM |
| Generic Name | HEPARIN SODIUM |
| Manufacturer | HEPARIN SODIUM |
| Original Package? | 1 |
| Active Substance | HEPARIN SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | USA Nationwide |
| Quantity | 28,875 vials |
| Recall Reason | Labeling: Not elsewhere classified |
| Drug Classification | Class II |
| Drug Code Info | 20230315 |
| Product NDC | 25021-404 |
| Recall Initiation Date | 20230228 |
| Report Date | 20230315 |
| Classification Date | 20230306 |
| Address | 1901 N Roselle Rd Ste 450 Schaumburg, IL 60195-3194 United States |
| Recalling Firm | Sagent Pharmaceuticals Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | ZZ45AB24CA |
| Drug Application Number | ANDA090809 |
| Structured Product Labeling (SPL ID) | bb6d321d-a569-4736-88a0-c979074d71ef |
| Structured Product Labeling (SPL Set ID) | feec2820-502f-4a97-84c9-f173729c51d3 |
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