Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility
| Brand name | LEADER ADVANCED RELIEF EYE DROPS, GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER, MEDICS CHOICE EYE DROPS ADVANCED, FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS, QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS |
| Generic name | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL, DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL, TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL |
| Active ingredient(s) | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE |
| Distributed by / for | CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com |
| NDC | 70000-0456-1 |
| Full product label | Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; d) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43745 0; e) Medic'c Choice, Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-025-01; f) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, NDC 70677-1158-1; g) Colirio Manzanill A+, Distributed by: PRO-MEX, P.O Box 63-0716, Miami , FL 33163, UPC: 1 84125 00018 0; h) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 06776 9; I) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; J) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3. |
| Recalling firm | K.C. Pharmaceuticals, Inc. |
| Distribution | US Nationwide |
| Quantity | 208,896 cartons |
| Recall initiated | 2026-09-11 |
| Report date | 2026-10-14 |
| Recall completed | — |
| Recall number | D-0004-2027 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pomona CA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗