FDAFDA · Food and drugs·Recall number D-0362-2024
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Published March 6, 2024 · Recall initiated: February 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Distributor
- Nationwide in the USA
- Lot
- Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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