FDAClass IIDecember 14, 2022

0.9% Sodium Chloride Injection USP recall: Sterility Concern

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA…

Why was 0.9% Sodium Chloride Injection USP recalled?

Lack of sterility assurance: Bags have the potential to leak.

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: 0061832446 Exp. 31 Oct 2024

Product
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA…
Recalling firm
B. Braun Medical, Inc.
Quantity
756 bags
Distribution
FL, NJ, PA
Recall date
December 14, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls