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Recall Observatory FDA recall evidence

Drug product

HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03

D-0324-2015

September 11, 2014

Class I

Product summary

Firm
Hospira Inc.
Event
Event 69214
Status
Terminated
Classification
Class I
Quantity
63,378 flexible container units
Official record key
drug-enforcement:D-0324-2015

Official wording

Reason: Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.

Code information: Lot #: 41-046-JT, Exp 11/01/2015

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter