FDAClass IIFebruary 23, 2022

Moxifloxacin Ophthalmic Solution recall: Impurity Out of Spec

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

Why was Moxifloxacin Ophthalmic Solution 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#: CMF210001, CMF210003, CMF210004, Exp 6/2023

Product
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
Recalling firm
Aurobindo Pharma USA Inc.
Quantity
115776 bottles
Distribution
USA Nationwide
Recall date
February 23, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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