The Recall Desk
ModerateFDA (Drugs)·D-1687-2012·Announced 2012-10-03

Baxter Recalls 10% Dextrose Injection Due to Chemical Contamination

Baxter Healthcare is recalling 2,976 containers of 10% Dextrose Injection USP due to potential trace levels of cumene hydroperoxide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the contamination is described as 'trace levels,' fitting the criteria for a moderate severity rating.

Plain-English summary

Baxter Healthcare Corporation is recalling 2,976 containers of 10% Dextrose Injection USP, packaged in 500 mL AVIVA containers. The product is prescription-only and was distributed nationwide and in Puerto Rico. The specific lot number is C832840 with an expiration date of 02/13.

The recall was initiated because the IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). This is a chemical contamination issue.

Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare for further instructions or a return.

The recalled product

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
Affected units
2,976

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: C832840
  • Exp 02/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →