Promise Pharmacy, LLC recalls Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise…

Recall date

December 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0433-2019

FDA classification

Class II

Brand / firm

Promise Pharmacy, LLC

Sold / distributed

Nationwide in the USA.

Why it was recalled

Lack of sterility assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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