Drug recall D-0789-2020

Class III Terminated reported Jan 22, 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.

Lots and codes

Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.

Recall details

Recalling firm
AuroMedics Pharma LLC, East Windsor, NJ
Quantity
100,080 bottles
Distribution
Nationwide in the U.S.
Type
Voluntary: Firm initiated
Recall initiated
December 2, 2019
Terminated
November 22, 2022

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