FDA-Drug2026-09-16Class IPROCESSING DEFECT
B. Braun 0.9% Sodium Chloride Injection recalled for particulate contamination
What this means
B. Braun Medical Inc. is recalling specific lots of 0.9% Sodium Chloride Injection due to the presence of particulate matter, including iron oxide, inorganic material, cellulose fibers, and polystyrene. The contamination was identified during quality testing. This is a sterile injectable product distributed nationwide.
- Check if your facility has lots J6B435, J6B444, or J6B457 with expiration date 30 APR 2027.
- Do not use affected vials. Quarantine them and contact your supplier or B. Braun Medical Inc. for instructions on return or disposal.
- Contact your healthcare provider or pharmacist if this product has already been administered to a patient.
The agency's original wording
Hazard
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Intended for
All ages
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
201,472 total container
Manufactured in
861 Marcon Blvd, Allentown, PA, United States
Products
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2026More B. Braun recalls
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