FDA Drug recall D-1490-2019
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals,…
- FDA Drug
- Class III
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class III recall of Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals,… by Lupin Pharmaceuticals, citing labeling: Missing label; Product complaints reported missing bottle label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1490-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-07-11 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
Reason
Labeling: Missing label; Product complaints reported missing bottle label.
Identifiers
| code_info | Lot #: H805157, Exp. 05/2020 |
|---|
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-1490-2019%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.