FDA-Drug2020-01-22Class III

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.

AuroMedics Pharma LLC
Hazard

Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

Sold states
Nationwide in the U.S.
Affected count
100,080 bottles
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
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.

Official notice

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

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