FDA Recall Moxifloxacin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Moxifloxacin with NDC 68180-422 was initiated on 02-26-2019 as a Class III recall due to failed impurities/degradation specifications: expansion of july 2018 and february 2019 recall due to high out-of-specification for impurities. The latest recall number for this product is D-0517-2019 and the recall is currently terminated as of 06-22-2020 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0517-2019 | 02-26-2019 | 03-06-2019 | Class III | 674,628 bottles | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01. | Terminated |
| D-0484-2019 | 02-01-2019 | 02-20-2019 | Class III | 43,860 3ml bottles | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01 | Terminated |
| D-1050-2018 | 07-26-2018 | 08-08-2018 | Class III | 13,896 bottles | 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 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.