FDAClass IIMarch 23, 2022

0.9% Sodium Chloride Injection USP recall: Sterility Concern

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20

Why was 0.9% Sodium Chloride Injection USP recalled?

Lack of sterility assurance: leaking bags

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 #: J1E086, J1E204, J1E213, Exp 5/31/2023; J1H137, J1H138, Exp 6/30/2023

Product
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Recalling firm
B. Braun Medical, Inc.
Quantity
33,742 bags
Distribution
USA Nationwide
Recall date
March 23, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls