AuroMedics Pharma LLC recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed…

Recall date

December 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0789-2020

FDA classification

Class III

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.