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.
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05
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 |
|---|---|---|---|---|
| Rite Aid Eye Drops Dry Eye Relief Glycerin, Hypromellose, Polyethylene glycol 400 NDC 11822-1067 |
GLYCERIN .2 g/100mL; HYPROMELLOSE, UNSPECIFIED .2 g/100mL; POLYETHYLENE GLYCOL 400 1 g/100mL | Solution Ophthalmic |
Rite Aid Corporation | OTC |
| Meijer Dry Eye Relief Glycerin, Hypromellose, Polyethylene glycol 400 NDC 41250-0718 |
GLYCERIN .2 g/100mL; POLYETHYLENE GLYCOL 400 1 g/100mL; HYPROMELLOSE, UNSPECIFIED .2 g/100mL | Solution/ Drops Ophthalmic |
Meijer Distribution, Inc. | OTC |
| Artificial Tears Glycerin NDC 57896-0181 |
.002 mg/mg; HYPROMELLOSES .002 mg/mg; POLYETHYLENE GLYCOL 400 .01 mg/mg | Solution/ Drops Ophthalmic |
Geri-Care Pharmaceuticals, Corp | OTC |
| Leader Dry Eye Relief Eye Drops Glycerin, Hypromellose, Polyethylene glycol 400 NDC 70000-0502 |
GLYCERIN .2 g/100mL; HYPROMELLOSE, UNSPECIFIED .2 g/100mL; POLYETHYLENE GLYCOL 400 1 g/100mL | Solution/ Drops Ophthalmic |
Cardinal Health 110, LLC. Dba Leader | OTC |
| Foster and Thrive Advanced Relief Eye Drops Polyethylene glycol 400, Tetrahydrozoline HCl NDC 70677-1158 |
TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL; POLYETHYLENE GLYCOL 400 1 g/100mL | Solution/ Drops Ophthalmic |
Strategic Sourcing Services LLC | 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.