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: Labeling: Incorrect or missing package insert.

Code information: Lot #s: 287880F, 287881F, Exp. 10/31/2019; 290555F, Exp. 11/30/2019; 293389F, Exp. 2/29/2020; 290556F, 290557F, 293386F, 293387F, Exp. 3/31/2020; 293388F, 293390F, Exp. 5/31/2020; 293391F, Exp. 6/30/2020; 293392F, Exp. 7/31/2020; 295342F, 298823F, Exp. 8/31/2020; 295344F, 295345F, 295346F, Exp. 10/31/2020; 295347F, 304496F, Exp. 11/30/2020; 298825F, Exp. 12/31/2020; 304495F, 304497F, Exp. 01/31/2021; 304963F, Exp. 3/31/2021; 304966F, Exp. 4/30/2021; 304964F, Exp. 5/31/2021.

Distribution pattern: Nationwide in the U.S.