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Recall Observatory FDA recall evidence

Drug product

1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.

D-0382-2015

April 18, 2014

Class I

Product summary

Firm
Hospira Inc.
Event
Event 69327
Status
Terminated
Classification
Class I
Quantity
120,900 vials
Official record key
drug-enforcement:D-0382-2015

Official wording

Reason: Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.

Code information: Lot number: 31-427-DK, Exp 01JUL2015.

Distribution pattern: Nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter