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Recall Observatory FDA recall evidence

Drug product

Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14

D-0832-2016

March 08, 2016

Class II

Product summary

Firm
Hospira Inc.
Event
Event 73472
Status
Terminated
Classification
Class II
Quantity
81888 bags
Official record key
drug-enforcement:D-0832-2016

Official wording

Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Code information: Lo# 53-006-JT, Exp 11/16

Distribution pattern: US: Nationwide and Singapore

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination