FDA-Drug2019-02-20Class II

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

Promise Pharmacy, LLC
Hazard

Lack of sterility assurance.

Sold states
Nationwide in the USA.
Affected count
900 3 ml bottles
Manufactured in
31818 Us Highway 19 N, N/A, Palm Harbor, FL, United States
Products
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

Official notice

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

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