FDAClass IIFebruary 20, 2019

Prednisolone and Moxifloxacin Ophthalmic Solution recall: Sterility Concern

Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm…

Why was Prednisolone and Moxifloxacin Ophthalmic Solution recalled?

Lack of sterility assurance.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 10252018@8 BUD: 2/10/2019

Product
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm…
Recalling firm
Promise Pharmacy, LLC
Quantity
43 3 mL bottles
Distribution
Nationwide in the USA.
Recall date
February 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls