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Recall Observatory FDA recall evidence

Drug product

Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.

D-1593-2014

July 11, 2014

Class I

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 68728
Status
Terminated
Classification
Class I
Quantity
171,672 bags
Official record key
drug-enforcement:D-1593-2014

Official wording

Reason: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

Code information: Lot #: P309476, Exp 10/14

Distribution pattern: Nationwide, Puerto Rico, Singapore, and Hong Kong

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter