Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL R...
FDA Recall #D-0434-2019 — Class II — December 17, 2018
Product Description
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/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
250 3 ml bottles
Distribution
Nationwide in the USA.
Code Information
Lots: 09262018@5 BUD: 1/15/2019; 10092018@1 BUD: 1/25/2019; 11052018@1 BUD: 2/21/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated