Reported Mar 6, 2024 · Ongoing

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

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 5mg/ml
    • 1 ml in a Single- Dose Vial
    • Rx Only
    • Leiters 13796 Compark Blvd
    • Englewood
    • CO 80112
    • NDC 71449-097-42
Lot codes and dates
  • Lot #:2331123
  • Exp
    • 28-Feb-24
    • 2331298
  • Exp24-Mar-24
Amount recalled
10,020 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Denver Solutions, LLC dba Leiters Health recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:04 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.