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Recall Observatory FDA recall evidence

Drug product

Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01

D-1033-2016

May 06, 2016

Class II

Product summary

Firm
Hospira Inc.
Event
Event 73992
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-1033-2016

Official wording

Reason: Presence of Particulate Matter: Cardboard

Code information: Lot #:565003A, Exp.01 Aug 2017

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter