FDAClass IIAugust 19, 2015

0.9% Sodium Chloride Injection USP recall: Particulate Matter

0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.

Why was 0.9% Sodium Chloride Injection USP recalled?

Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.

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 #: C964601, Exp 4/30/2016

Product
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Recalling firm
Baxter Healthcare Corp.
Quantity
189,912 containers
Distribution
TX and TN
Recall date
August 19, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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