The Recall Desk
SevereFDA (Drugs)·D-1686-2012·Announced 2012-10-03

Baxter Recalls 5% Dextrose Injection Due to Chemical Contamination

Baxter Healthcare is recalling 5% Dextrose Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Baxter Healthcare Corporation is recalling 5% Dextrose Injection USP packaged in AVIVA containers. The recall involves 753,941 containers of the 250 mL and 500 mL sizes, distributed nationwide and in Puerto Rico. The product is prescription-only and is identified by specific lot numbers and expiration dates ranging from September 2012 to February 2014.

The recall was initiated because the IV solutions were packaged in AVIVA containers that may contain trace levels of cumene hydroperoxide (CHP). This chemical contamination poses a potential risk to patients receiving the infusion.

Healthcare providers and patients should check their inventory and records for the affected lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to Baxter's instructions.

The recalled product

Product
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Manufacturer
Baxter Healthcare Corp.
Category
Drug — IV Solution
Hazard
Affected units
753,941

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 (20)

  • Lot #: a) C841114
  • C841254
  • Exp 09/12
  • C842229
  • C842898
  • C843037
  • C843326
  • C844209
  • Exp 10/12
  • C844456
  • C844928
  • C846089
  • C846246
  • C847178
  • Exp 11/12
  • C848044
  • C848804
  • C849869
  • C849810
  • C850313

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 →

Related recalls

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · chemical contamination

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