FDA recall D-0239-2019
Promise Pharmacy LLC · Class III · drug
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
Distribution
U.S.A. Nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2018-10-18
- Report date
- 2018-10-31
- Termination date
- 2020-10-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Palm Harbor, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0239-2019