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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