Reported Feb 20, 2019 · Terminated

Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise…

Promise Pharmacy, 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: Promise Pharmacy, LLC · 31818 Us Highway 19 N · Palm Harbor, FL · 34684-3713

Is this the product you have?

  • Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Lot codes and dates
  • Lots09262018@6
  • BUD
    • 12/25/2018
    • 11052018@2
  • BUD2/3/2019
Amount recalled
167 3 ml bottles

This recall covers 51 products

The agency filed one notice per product. You are reading one of them; the other 50 are below.

38 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Lack of sterility assurance.

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

Notice updated Mar 30, 2021 · Data as of Sep 19, 7:23 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.