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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.

D-1326-2015

July 02, 2015

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 71627
Status
Terminated
Classification
Class II
Quantity
189,912 containers
Official record key
drug-enforcement:D-1326-2015

Official wording

Reason: Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.

Code information: Lot #: C964601, Exp 4/30/2016

Distribution pattern: TX and TN

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility