0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, ND
Summary
The FDA issued a Class I for 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical by B BRAUN MEDICAL INC. Reason: Presence of Particulate Matter..
Details
Source
Drug Recall
External ID
D-0628-2025
Action Date
2025-09-10
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: V3K770, Exp 1/31/2026
Quantity Affected: 47,148 containers
Reason for Recall
Presence of Particulate Matter.
Distribution
U.S.A. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-18
Company
Allentown, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
B BRAUN MEDICAL INC has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B BRAUN MEDICAL INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B BRAUN MEDICAL INC have FDA actions?
B BRAUN MEDICAL INC has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0628-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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