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 #: H805157Exp. 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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