FDAClass IIMarch 9, 2022

Moxifloxacin Ophthalmic Solution USP 0.5% recall: Impurity Out of Spec

Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05

Why was Moxifloxacin Ophthalmic Solution USP 0.5% recalled?

Failed impurities/degradation specifications

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#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23

Product
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
Recalling firm
Direct Rx
Quantity
44 bottles
Distribution
Florida
Recall date
March 9, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls