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Recall Observatory FDA recall evidence

Drug product

1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.

D-1234-2014

September 16, 2013

Class I

Product summary

Firm
Hospira, Inc.
Event
Event 66441
Status
Terminated
Classification
Class I
Quantity
374,500 vials
Official record key
drug-enforcement:D-1234-2014

Official wording

Reason: Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.

Code information: Lot #25090DK; Exp 01/15

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter