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Recall Observatory FDA recall evidence

Drug product

5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03

D-1688-2012

September 21, 2012

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 63189
Status
Terminated
Classification
Class II
Quantity
5,064 containers
Official record key
drug-enforcement:D-1688-2012

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 #: C828814, Exp 12/12; C841551, Exp 04/13

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination