Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL,...
FDA Recall #D-0435-2019 — Class II — December 17, 2018
Product Description
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 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
2057 6 ml bottles
Distribution
Nationwide in the USA.
Code Information
Lots: 09192018@4 BUD: 12/18/2018; 10112018@1 BUD: 12/24/2018; 10262018@1 BUD: 1/8/2019; 10302018@1 BUD: 1/12/2019; 11082018@6 BUD: 1/21/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated