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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23

D-922-2013

August 31, 2012

Class I

Product summary

Firm
Hospira Inc.
Event
Event 63364
Status
Terminated
Classification
Class I
Quantity
264,432 bags
Official record key
drug-enforcement:D-922-2013

Official wording

Reason: Presence of Particulate Matter; product may contain fibrous material

Code information: Lot Number 05-201-JT, Expiration Date 1MAY2013

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter