Reported Mar 6, 2024 · Ongoing

Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose…

Denver Solutions, LLC dba Leiters Health

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Denver Solutions, LLC DBA Leiters Health · 13796 Compark Blvd · Englewood, CO · 80112-7145

Is this the product you have?

  • 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
Lot codes and dates
  • 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
  • Exp29-May-24
Amount recalled
40,090 vials

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.