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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.

D-481-2015

December 04, 2014

Class I

Product summary

Firm
Baxter Healthcare Corp
Event
Event 69962
Status
Terminated
Classification
Class I
Quantity
542,080 container bags
Official record key
drug-enforcement:D-481-2015

Official wording

Reason: Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.

Code information: Lot #: P317891, P317842, Exp 05/15

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter