Drug product
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
D-1050-2018
Product summary
- Event
- Event 80668
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,896 bottles
- Official record key
drug-enforcement:D-1050-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Code information: Lot #: H800393, Exp. 01/2020
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Potency or specification failure
out-of-specification