Intravenous Sodium Chloride Injection Recalled for Incomplete Labeling and Warnings
B. Braun Medical Inc. is recalling 43,812 bags of 0.9% Sodium Chloride Injection due to incomplete or missing labeling, including warnings and instructions for use.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for incomplete or missing labeling on a prescription intravenous medication. Per the severity rubric, FDA Class III recalls typically score 1–2, and this minor labeling error falls under the Moderate (2) category. The source does not report any illnesses or injuries in connection with the recall.
Plain-English summary
B. Braun Medical Inc. is recalling 43,812 bags of 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, distributed throughout the United States. The product is a prescription intravenous medication.
The recall is due to incomplete or missing labeling on affected lots. The product description, warnings, storage information, and instructions for use are either missing or only partially printed.
The affected lot is #0061852531, expiring 2/28/2025. Healthcare facilities and clinicians should immediately stop using the product and contact B. Braun Medical Inc. for return and replacement instructions.
The FDA classified this recall as Class III.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc.
- Category
- Drug — Intravenous
- Affected units
- 43,812
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 0061852531
- Exp 2/28/2025
Distribution
Distribution scope not specified by the agency.
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