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Recall Observatory FDA recall evidence

Drug product

5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

D-66201-001

August 29, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 66201
Status
Terminated
Classification
Class II
Quantity
86,400 ampuls
Official record key
drug-enforcement:D-66201-001

Official wording

Reason: Presence of Particulate Matter; report of visible particulates in the glass ampule

Code information: Lot 23-227-DK

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter