Drug Enforcement D-0628-2025

Presence of Particulate Matter.

Status

Ongoing

Classification

Class I

Report Date

September 10, 2025

Termination Date

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Product Information

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
Product quantity
47,148 containers
Reason for recall
Presence of Particulate Matter.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S.A. Nationwide

Location & Firm

Recalling firm
B BRAUN MEDICAL INC
Address
861 Marcon Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0628-2025
Event ID
97433
Recall initiation date
August 18, 2025
Center classification date
September 10, 2025
Code info
Lot #: V3K770, Exp 1/31/2026
More code info
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