FDAClass IISeptember 30, 2015

0.9% Sodium Chloride Injection recall: Sterility Concern

0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL…

Why was 0.9% Sodium Chloride Injection recalled?

Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of 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 #: P329821, Exp 08/31/2016

Product
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL…
Recalling firm
Baxter Healthcare Corporation
Quantity
139,104 Bags
Distribution
Nationwide and Puerto Rico
Recall date
September 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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