FDA recall D-0491-2025

Product

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.

Reason for recall

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2025-06-16

Report date

2025-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0491-2025