FDA Drug Class II — Moderate

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

Hazard

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

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Products

Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Brand
Denver Solutions, LLC DBA Leiters Health
UPC
Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.

Units Affected

10,020 vials

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