FDA recall D-0434-2023

B. Braun Medical Inc · Class II · drug

Product

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.

Reason for recall

Subpotent Drug: low Anti-Factor IIa potency.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2023-03-01
Report date: 2023-03-15
Termination date: 2024-03-13
Voluntary/Mandated: —
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0434-2023