Artificial Tears Sterile Lubricant Eye Drops
Lack of Assurance of Sterility
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Cause type: Sterility / contamination
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.
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9.
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
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 |
|---|---|---|---|---|
| Meijer Ultra Lubricant Eye Drops High Performance Polyethylene glycol 400, Propylene glycol NDC 41250-0937 |
POLYETHYLENE GLYCOL 400 .4 g/100mL; PROPYLENE GLYCOL .3 g/100mL | Solution/ Drops Ophthalmic |
Meijer Distribution, Inc. | OTC |
| GoodSense Ultra Lubricant Eye Drops polyethylene glycol 400, propylene glycol NDC 50804-0160 |
PROPYLENE GLYCOL .3 g/100mL; POLYETHYLENE GLYCOL 400 .4 g/100mL | Solution Ophthalmic |
Geiss, Destin & Dunn, Inc. | OTC |
| Leader Ultra Lubricating Eye Drops Polyethylene glycol 400, propylene glycol NDC 70000-0457 |
POLYETHYLENE GLYCOL 400 .4 g/100mL; PROPYLENE GLYCOL .3 g/100mL | Solution/ Drops Ophthalmic |
Cardinal Health | OTC |
| Foster and Thrive Lubricating Tears Lubricant Eye Drops Polyethylene glycol 400, Propylene glycol NDC 70677-1160 |
POLYETHYLENE GLYCOL 400 .4 g/100mL; PROPYLENE GLYCOL .3 g/100mL | Solution/ Drops Ophthalmic |
Strategic Sourcing Services LLC | OTC |
| Quality Choice Lubricant Eye Drops High Performance Polyethylene glycol 400, Propylene glycol NDC 83324-0029 |
POLYETHYLENE GLYCOL 400 .4 g/100mL; PROPYLENE GLYCOL .3 g/100mL | Solution/ Drops Ophthalmic |
Chain Drug Marketing Assoc., Inc. | OTC |
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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.