FDAClass IISeptember 17, 2014

0.9% Sodium Chloride Injection recall: Sterility Concern

0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03

Why was 0.9% Sodium Chloride Injection recalled?

Lack of Assurance of Sterility; complaints of mold in the overpouch

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 #C926642, Product Code: 2B1323N

Product
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
Recalling firm
Baxter Healthcare Corp.
Quantity
157,080 containers
Distribution
Nationwide
Recall date
September 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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