Reported Aug 26, 2015 · Terminated

Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL…

Bausch & Lomb, Inc.

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: Bausch & Lomb, Inc. · 8500 Hidden River Pkwy · Tampa, FL · 33637-1014

Is this the product you have?

  • Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637
  • NDC24208-439-01
Lot codes and dates
  • Lot #221211
  • Expiry09/30/2015
Amount recalled
13,995 Bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Lack of Assurance of Sterility: Failed preservative effectiveness testing.

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 Apr 7, 2017 · Data as of Sep 19, 7:53 PM UTC

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