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Recall Observatory FDA recall evidence

Drug product

5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02

D-1209-2015

March 24, 2015

Class I

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 70926
Status
Terminated
Classification
Class I
Quantity
402,284 bags
Official record key
drug-enforcement:D-1209-2015

Official wording

Reason: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Code information: Lot #: C963413 and C963413A, Exp 7/31/2016

Distribution pattern: US, Puerto Rico, and Bermuda

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter