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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

D-836-2013

March 29, 2013

Class I

Product summary

Firm
Hospira Inc.
Event
Event 64792
Status
Terminated
Classification
Class I
Quantity
691,356 containers
Official record key
drug-enforcement:D-836-2013

Official wording

Reason: Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates

Code information: Lot #: 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter