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,
Reported: May 24, 2023 Initiated: May 9, 2023 #D-0579-2023
Product Description
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 for Recall
Subpotent: Low anti-factor IIa Potency.
Details
- Recalling Firm
- B. Braun Medical Inc
- Units Affected
- 1,380
- Distribution
- Nationwide in the USA
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by B. Braun Medical Inc. Units affected: 1,380.
Why was this product recalled? ▼
Subpotent: Low anti-factor IIa Potency.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 24, 2023. Severity: Moderate. Recall number: D-0579-2023.
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