Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic ...
FDA Recall #D-0789-2020 — Class III — December 2, 2019
Product Description
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.
Recalling Firm
AuroMedics Pharma LLC — East Windsor, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
100,080 bottles
Distribution
Nationwide in the U.S.
Code Information
Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated