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Recall Observatory FDA recall evidence

Drug product

Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42

D-0362-2024

February 20, 2024

Class II

Product summary

Firm
Denver Solutions, LLC DBA Leiters Health
Event
Event 94071
Status
Ongoing
Classification
Class II
Quantity
10,020 vials
Official record key
drug-enforcement:D-0362-2024

Official wording

Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Code information: Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter