FDAClass IIIAugust 16, 2023

0.9% Sodium Chloride Injection USP recall: Labeling Error

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

Why was 0.9% Sodium Chloride Injection USP recalled?

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 0061852531, Exp 2/28/2025

Product
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Recalling firm
B. Braun Medical Inc.
Quantity
43,812 bags
Distribution
United States
Recall date
August 16, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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