FDA Drug recall D-0579-2023
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc
- FDA Drug
- Class II
- terminated
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc by B Braun Medical, citing subpotent: Low anti-factor IIa Potency.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0579-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-05-09 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,
Reason
Subpotent: Low anti-factor IIa Potency.
Identifiers
| ndc | 0264-9567-10 |
|---|---|
| ndc | 0264-9577-10 |
| ndc | 0264-9587-20 |
| code_info | Lot Number: J1P154N, Exp: 31 May, 2023, |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0579-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.