FDAClass IIIJanuary 22, 2020

Moxifloxacin Ophthalmic Solution USP recall

Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.

Why was Moxifloxacin Ophthalmic Solution USP recalled?

Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

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 #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.

Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
Recalling firm
AuroMedics Pharma LLC
Quantity
100,080 bottles
Distribution
Nationwide in the U.S.
Recall date
January 22, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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