Drug recall
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N…
FDA recall event 81351 · Class III · Promise Pharmacy LLC
Key facts
| Event ID | 81351 |
|---|---|
| Recall numbers | D-0239-2019 |
| Recalling firm | Promise Pharmacy LLC |
| Product type | Drugs |
| Products | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of precipitate |
| Initiation date | Oct 18, 2018 |
| Report date | Oct 31, 2018 |
| Termination date | Oct 22, 2020 |
| City | Palm Harbor |
| State | FL |
| Country | United States |
| FEI number | 3013207472 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: