FDA recall D-0637-2022

Direct Rx · Class II · drug

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

Reason for recall

Failed impurities/degradation specifications

Distribution

Florida

Key facts

Status: Terminated
Initiation date: 2022-02-17
Report date: 2022-03-09
Termination date: 2023-10-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0637-2022