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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02

D-0969-2015

January 20, 2015

Class I

Product summary

Firm
Hospira Inc.
Event
Event 70303
Status
Terminated
Classification
Class I
Quantity
661,128 containers
Official record key
drug-enforcement:D-0969-2015

Official wording

Reason: Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.

Code information: Lot #: 44-002-JT (the lot number may be followed by 01 to 99), Exp 08/01/2016

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter