Artificial Tears Sterile Lubricant Eye Drops (Polyvinyl Alcohol, Povidone)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14

Affected NDCs 24385-0006-05 50804-0110-01 70000-0011-01 83324-0189-14

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol Category: Eye Drops & Ophthalmic

Product details

From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops polyvinyl alcohol, povidone NDC 24385-0006	POLYVINYL ALCOHOL, UNSPECIFIED .5 g/100mL; POVIDONE .6 g/100mL	Solution/ Drops Ophthalmic	AmerisourceBergen	OTC
Good Sense Artificial Tears polyvinyl alcohol, povidone NDC 50804-0110	POLYVINYL ALCOHOL, UNSPECIFIED .5 g/100mL; POVIDONE .6 g/100mL	Solution Ophthalmic	Geiss, Destin & Dunn, Inc.	OTC
Leader Artificial Tears 15 mL Polyvinyl Alcohol, Povidone NDC 70000-0011	POLYVINYL ALCOHOL, UNSPECIFIED .5 g/100mL; POVIDONE .6 g/100mL	Solution/ Drops Ophthalmic	Cardinal Health	OTC
Quality Choice Artificial Tears Lubricant Eye Drops Polyvinyl alcohol, Povidone NDC 83324-0189	POLYVINYL ALCOHOL .5 g/100mL; POVIDONE .6 g/100mL	Solution/ Drops Ophthalmic	Chain Drug Marketing Association, Inc.	OTC

Recalling firm: K.C. Pharmaceuticals, Inc
NDC code: 70000-0011-1
Origin: CA, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0416-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.