The Recall Desk
ModerateFDA (Drugs)·D-1690-2012·Announced 2012-10-03

Baxter Recalls Lactated Ringer's Injection Due to Chemical Contamination

Baxter Healthcare is recalling specific lots of Lactated Ringer's 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, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a low-risk contamination scenario.

Plain-English summary

Baxter Healthcare Corporation is recalling 55,664 containers of Lactated Ringer's Injection USP. The affected products are packaged in 250 mL and 500 mL AVIVA containers and are distributed nationwide and in Puerto Rico.

The recall is due to chemical contamination. The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Healthcare providers and patients should check their inventory and discontinue use of the affected lots. The specific lot numbers and expiration dates are: 250 mL containers (C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13) and 500 mL containers (C855445, Exp 09/13; C861492, Exp 12/13).

The recalled product

Product
Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Manufacturer
Baxter Healthcare Corp.
Category
Drug — IV Solutions
Hazard
Affected units
55,664

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 (10)

  • Lot #: a) C847749
  • Exp 11/12
  • C847897
  • Exp 12/12
  • C860668
  • Exp 04/13
  • b) C855445
  • Exp 09/13
  • C861492
  • Exp 12/13

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 →

Related recalls

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · chemical contamination

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