PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 23, 2022 Initiated: January 14, 2022 #D-0560-2022

Product Description

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

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Recalling Firm
Aurobindo Pharma USA Inc.
Units Affected
115776 bottles
Distribution
USA Nationwide
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 115776 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 23, 2022. Severity: Moderate. Recall number: D-0560-2022.