D-0628-2025 Class I Ongoing

Recalled by B BRAUN MEDICAL INC — Allentown, PA

FDA drug recall D-0628-2025 was initiated by B BRAUN MEDICAL INC on August 18, 2025 and is designated Class I. Reason for recall: Presence of Particulate Matter. The recall status is ongoing. Affected quantity: 47,148 containers.

Recall Details

Product Type
Drugs
Report Date
September 10, 2025
Initiation Date
August 18, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47,148 containers

Product Description

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

Reason for Recall

Presence of Particulate Matter.

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: V3K770, Exp 1/31/2026