Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-1690-2012

September 21, 2012

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 63189
Status
Terminated
Classification
Class II
Quantity
55,664 containers
Official record key
drug-enforcement:D-1690-2012

Official wording

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

Code information: Lot #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination