Sandoz Inc recalls Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured…

Recall date

October 17, 2019

Source

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

Recall number

D-0162-2020

FDA classification

Class III

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Labeling: Incorrect or missing package insert.

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

What was recalled

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