Sandoz Inc recalls Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon
Recalled November 6, 2019 · FDA recall D-0163-2020 · Sandoz
Hazard
Labeling: Incorrect or missing package insert. · FDA Class III
Units
76,644 bottles
Sold at
Nationwide in the U.S.
Description
Labeling: Incorrect or missing package insert.
Product
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.
Manufacturer(s)
Sandoz Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →