Reported Jul 24, 2019 · Terminated

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for:…

Lupin Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174

Is this the product you have?

  • Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle
  • Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States
  • Manufactured byLupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01
Lot codes and dates
    • Lot #: H805157
    • Exp. 05/2020
Amount recalled
17,238 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Labeling: Missing label; Product complaints reported missing bottle label.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 9, 2020 · Data as of Sep 19, 8:05 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.