FDA Drug recall D-1050-2018
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc
- FDA Drug
- Class III
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class III recall of Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1050-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-07-26 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Identifiers
| ndc | 68180-422-01 |
|---|---|
| code_info | Lot #: H800393, Exp. 01/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1050-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.