Skip to content
Recall Observatory FDA recall evidence

Drug product

Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.

D-099-2013

October 04, 2012

Class II

Product summary

Firm
Hospira, Inc.
Event
Event 63913
Status
Terminated
Classification
Class II
Quantity
120,350 vials
Official record key
drug-enforcement:D-099-2013

Official wording

Reason: Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.

Code information: Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter