Product: Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
Reason for recall: Labeling: Missing label; Product complaints reported missing bottle label.
Recall initiated: 20190711
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated