FDA-Drug2019-09-18Class III
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
Mylan Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Sold states
Nationwide in the USA
Affected count
13,157 5 mL bottles
Manufactured in
781 Chestnut Ridge Rd, Morgantown, WV, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1848-2019Don't want to check this manually?
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