Mylan Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV
Recalled September 18, 2019 · FDA recall D-1848-2019 · Mylan Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications:OOS for unknown impurity. · FDA Class III
Units
13,157 5 mL bottles
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
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
Manufacturer(s)
Mylan Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →