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
Recall Number: D-1848-2019
Firm: Mylan Pharmaceuticals Inc.
Classification: Class III
Status: Terminated
Report Date: 20190918
Initiation Date: 20190906
Termination Date: 20200716
Reason for Recall
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Product Description
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