FDA recall D-0436-2019

Product

Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

Reason for recall

Lack of sterility assurance.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2018-12-17

Report date

2019-02-20

Termination date

2021-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Harbor, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2019