0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx onl
Summary
The FDA issued a Class II for 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers by B BRAUN MEDICAL INC. Reason: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks..
Details
Source
Drug Recall
External ID
D-0491-2025
Action Date
2025-07-02
Status
Ongoing
Category
drug
Product Description
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Lot/Code Info: Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Quantity Affected: 187,656 containers
Reason for Recall
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-16
Company
Allentown, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 57 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0491-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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