Sandoz Inc recalls Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon…

Recall date

October 17, 2019

Source

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

Recall number

D-0163-2020

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

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.