FDA recall D-0162-2020

Sandoz Inc · Class III · drug

Product

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

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-0162-2020