FDAFDA · Food and drugs·Recall number D-0361-2024
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
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 #:2331147, Exp:6-Mar-24; 2331180, Exp: 21-Mar-24; 2331256, Exp: 2-Apr-24; 2331279, Exp: 3-Apr-24; 2331283, Exp: 7-Apr-24; 2331345, Exp: 20-Apr-24; 2331422, Exp: 27-Apr-24; 2331563, Exp: 29-May-24.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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