Product: Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for:  Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
Reason for recall: Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Recall initiated: 20190906
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated