FDA Drug recall D-0239-2019
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
- FDA Drug
- Class III
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class III recall of Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684 by Promise Pharmacy, citing presence of precipitate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0239-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-10-18 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Promise Pharmacy |
| Distribution | US |
Product
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason
Presence of precipitate
Identifiers
| code_info | Lot#: 04092018@2, Exp 12/03/2018 |
|---|
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-0239-2019%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.