Reported Feb 2, 2022 · Terminated

Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical…

Edge Pharma, LLC

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: Edge Pharma, LLC · 856 Hercules Dr · Colchester, VT · 05446-8014

Is this the product you have?

  • Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
Lot codes and dates
  • 10-2021-20@1 02/10/2022
Amount recalled
80 droppers

This recall covers 56 products

The agency filed one notice per product. You are reading one of them; the other 55 are below.

43 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility.

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

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

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 7, 2023 · Data as of Sep 19, 8:06 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.