Class III
Terminated
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
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- September 6, 2019
- Posted
- September 18, 2019
- Recall Number
- D-1848-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,157 5 mL bottles
- Firm Location
- Morgantown, WV, United States
Reason for Recall
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Distribution
Nationwide in the USA
Lot / Code Info
Lot GABH0003, EXP 7/2020
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