FDA recall D-0560-2022

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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-01-14

Report date

2022-02-23

Termination date

2024-07-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0560-2022