FDA Recall Heparin Sodium In Dextrose

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Heparin Sodium In Dextrose with NDC 0264-9587 was initiated on 05-09-2023 as a Class II recall due to subpotent: low anti-factor iia potency. The latest recall number for this product is D-0579-2023 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0579-202305-09-202305-24-2023Class II1,380Heparin 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,Ongoing
D-0434-202303-01-202303-15-2023Class II30672Heparin 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.Ongoing
D-1343-201906-13-201906-19-2019Class II40,176 bagsHeparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.