FDA recall D-0163-2020

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.

Reason for recall

Labeling: Incorrect or missing package insert.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2019-10-17

Report date

2019-11-06

Termination date

2022-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2020