FDA-Drug2019-11-06Class III

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06

Sandoz Inc
Hazard

Labeling: Incorrect or missing package insert.

Sold states
Nationwide in the U.S.
Affected count
346,929 bottles
Manufactured in
100 College Rd W, Princeton, NJ, United States
Products
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0162-2020

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