D-0869-2026 Class I Ongoing

Recalled by B BRAUN MEDICAL INC — Allentown, PA

FDA drug recall D-0869-2026 was initiated by B BRAUN MEDICAL INC on August 19, 2026 and is designated Class I. Reason for recall: Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene The recall status is ongoing. Affected quantity: 201,472 total container.

Recall Details

Product Type
Drugs
Report Date
September 16, 2026
Initiation Date
August 19, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
201,472 total container

Product Description

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.

Reason for Recall

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.