FDAClass IIOctober 3, 2012

10% Dextrose Injection USP recall: Contamination

10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03

Why was 10% Dextrose Injection USP recalled?

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

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 #: C832840, Exp 02/13

Product
10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
Recalling firm
Baxter Healthcare Corp.
Quantity
2,976 containers
Distribution
Nationwide and Puerto Rico
Recall date
October 3, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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