FDAClass IIJuly 3, 2013

0.9% Sodium Chloride Injection recall: Labeling Error

0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11

Why was 0.9% Sodium Chloride Injection recalled?

Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.

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: P293118; Exp Date: 10/13

Product
0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
Recalling firm
Baxter Healthcare Corp.
Quantity
317,280 bags
Distribution
Nationwide and Singapore
Recall date
July 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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