FDAClass IIJuly 19, 2023

0.9% Sodium Chloride Injection USP recall: Sterility Concern

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

Why was 0.9% Sodium Chloride Injection USP recalled?

Lack of assurance of sterility: 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#: 0061858305, 0061858306 Exp 3/31/2025

Product
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Recalling firm
B. Braun Medical Inc.
Quantity
79,880 bags
Distribution
USA Nationwide
Recall date
July 19, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls