Drug & medication recalls Moderate risk

Promise Pharmacy, LLC recalls Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Ph…

Recall date
December 17, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0437-2019
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 Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

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