Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded ...
FDA Recall #D-0433-2019 — Class II — December 17, 2018
Product Description
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
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
55 3 ml bottles
Distribution
Nationwide in the USA.
Code Information
Lot: 11052018@4 BUD: 1/18/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated