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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Hazard
- 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
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.
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