FDA recall D-0789-2020

Product

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

Reason for recall

Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2019-12-02

Report date

2020-01-22

Termination date

2022-11-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0789-2020