FDA recall D-0579-2023

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 for recall

Subpotent: Low anti-factor IIa Potency.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-05-09

Report date

2023-05-24

Termination date

2024-03-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0579-2023