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Recall Observatory FDA recall evidence

Drug product

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

D-1484-2020

July 07, 2020

Class I

Product summary

Firm
Mylan Institutional LLC
Event
Event 85956
Status
Terminated
Classification
Class I
Quantity
18,480 vials
Official record key
drug-enforcement:D-1484-2020

Official wording

Reason: Presence of Particulate Matter

Code information: Lot #: 7605112, Exp 10/2021

Distribution pattern: USA Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter