DEXTROSE MONOHYDRATE Recall D-0434-2023
Description: Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
DEXTROSE MONOHYDRATE Recall D-0434-2023 Information
| Status | Ongoing |
| Recall Number | D-0434-2023 |
| Event ID | 91769 |
| Brand | HEPARIN SODIUM IN DEXTROSE |
| Generic Name | HEPARIN SODIUM AND DEXTROSE |
| Manufacturer | HEPARIN SODIUM AND DEXTROSE |
| Original Package? | 1 |
| Active Substance | DEXTROSE MONOHYDRATE HEPARIN SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 30672 |
| Recall Reason | Superpotent Drug: low Anti-Factor IIa potency. |
| Drug Classification | Class II |
| Drug Code Info | 20230315 |
| Product NDC | 0264-9567 0264-9577 0264-9587 |
| Recall Initiation Date | 20230301 |
| Report Date | 20230315 |
| Classification Date | 20230306 |
| Address | 2525 Mcgaw Ave Irvine, CA 92614-5841 United States |
| Recalling Firm | B. Braun Medical Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | LX22YL083G ZZ45AB24CA |
| Drug Application Number | NDA019952 |
| Structured Product Labeling (SPL ID) | e0b6b21d-6bbb-4d4a-b332-8bb2b18fabd0 |
| Structured Product Labeling (SPL Set ID) | 92a6f533-1a3d-4734-b413-d245592454e3 |
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