Prednisolone and Gatifloxacin Ophthalmic Solution — Class III drug recall D-0239-2019
Terminated recall by Promise Pharmacy LLC, reported 2018-10-31, distributed nationwide. Presence of precipitate
| Recall number | D-0239-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Promise Pharmacy LLC, Palm Harbor, FL, United States |
| Recall initiated | 2018-10-18 |
| Classified | 2018-11-08 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-10-22 |
| Distributed | Nationwide (US) |
| Expiration dates | 2018-12-03 |
Product
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason for recall
Presence of precipitate
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0239-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.