D-0579-2023 Class II Terminated

Recalled by B. Braun Medical Inc — Irvine, CA

Recall Details

Product Type
Drugs
Report Date
May 24, 2023
Initiation Date
May 9, 2023
Termination Date
March 14, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,380

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot Number: J1P154N, Exp: 31 May, 2023,