← FDA ENFORCEMENT
D-0628-2025Class I

B BRAUN MEDICAL INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
B BRAUN MEDICAL INC
Product type
Drug
Status
Ongoing
Report date
2025-09-10
Distribution
U.S.A. Nationwide
Firm state
PA
Product quantity
47,148 containers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter.

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

Code / lot info

Lot #: V3K770, Exp 1/31/2026

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →