Drug 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
D-1848-2019
Product summary
- Event
- Event 83673
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,157 5 mL bottles
- Official record key
drug-enforcement:D-1848-2019
Official wording
Reason: Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Code information: Lot GABH0003, EXP 7/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications