FDAClass IIApril 1, 2015

0.9% Sodium Chloride Injection recall: Sterility Concern

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina…

Why was 0.9% Sodium Chloride Injection recalled?

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

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 #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.

Product
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina…
Recalling firm
Baxter Healthcare Corp.
Quantity
597,498 units total
Distribution
Nationwide
Recall date
April 1, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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