PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 9, 2022 Initiated: February 17, 2022 #D-0637-2022

Product Description

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

Reason for Recall

Failed impurities/degradation specifications

Details

Recalling Firm
Direct Rx
Units Affected
44 bottles
Distribution
Florida
Location
Dawsonville, GA

Frequently Asked Questions

What product was recalled?
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. Recalled by Direct Rx. Units affected: 44 bottles.
Why was this product recalled?
Failed impurities/degradation specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on March 9, 2022. Severity: Moderate. Recall number: D-0637-2022.