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Recall Observatory FDA recall evidence

Drug product

Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02

D-0123-2018

August 30, 2017

Class I

Product summary

Firm
Pfizer Inc.
Event
Event 78000
Status
Terminated
Classification
Class I
Quantity
102,500 vials
Official record key
drug-enforcement:D-0123-2018

Official wording

Reason: Presence of Particulate Matter: glass particulate found in vial

Code information: Lot: 632153A; Exp. 03/18

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter