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Recall Observatory FDA recall evidence

Drug product

Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.

D-813-2013

June 27, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 65731
Status
Terminated
Classification
Class II
Quantity
268,700 vials
Official record key
drug-enforcement:D-813-2013

Official wording

Reason: Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.

Code information: Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01

Distribution pattern: Nationwide and Guam

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter