FDAClass IIJanuary 18, 2023

Moxifloxacin Ophthalmic Solution recall: CGMP Deviations

Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05

Why was Moxifloxacin Ophthalmic Solution recalled?

cGMP deviation: discontinue of stability support for product.

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 #: 07MA2232, Exp. 4/30/23

Product
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
Recalling firm
Direct Rx
Quantity
11 bottles
Distribution
FL
Recall date
January 18, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls