Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Pr...
FDA Recall #D-0437-2019 — Class II — December 17, 2018
Product Description
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
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Promise Pharmacy, LLC — Palm Harbor, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
167 3 ml bottles
Distribution
Nationwide in the USA.
Code Information
Lots: 09262018@6 BUD: 12/25/2018; 11052018@2 BUD: 2/3/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated