Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. o...
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7
Affected Products
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7
Additional Source Details
| Field | Value |
|---|---|
| City | Pomona |
| State | CA |
| Openfda › Upc › 1 | 0635515995055 |
| Openfda › Upc › 2 | 0846036008210 |
| Openfda › Upc › 3 | 0041250829188 |
| Openfda › Upc › 4 | 070038470106 |
| Openfda › Upc › 5 | 093351011580 |
| Openfda › Upc › 6 | 311917179544 |
| Openfda › Upc › 7 | 041163251144 |
| Openfda › Upc › 8 | 036800036406 |
| Openfda › Upc › 9 | 041220437467 |
| Openfda › Unii › 1 | 0YZT43HS7D |
| Openfda › Unii › 2 | 89DS0H96TB |
| Openfda › Unii › 3 | B697894SGQ |
| Openfda › Unii › 4 | 6DC9Q167V3 |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui › 1 | 1043249 |
| Openfda › Rxcui › 2 | 477589 |
| Openfda › Spl id › 1 | 4749597d-57d7-92b6-e063-6294a90ab574 |
| Openfda › Spl id › 2 | 474511c4-1fbd-70b8-e063-6294a90af8e8 |
| Openfda › Spl id › 3 | 0d22c2c2-a705-2509-e063-6294a90ae206 |
| Openfda › Brand name › 1 | QUALITY CHOICE EYE DROPS IRRITATION RELIEF |
| Openfda › Brand name › 2 | GOODSENSE ULTRA LUBRICANT EYE DROPS |
| Openfda › Brand name › 3 | MEIJER SEASONAL ITCHING AND REDNESS RELIEF |
| Openfda › Spl set id › 1 | 1f682079-6e91-e14b-e063-6394a90a3f12 |
| Openfda › Spl set id › 2 | 9b45ebb5-c43b-c9fb-e053-2a95a90a3411 |
| Openfda › Spl set id › 3 | 9fead2de-2fe6-4dab-e053-2995a90a2742 |
| Openfda › Package ndc › 1 | 83324-190-14 |
| Openfda › Package ndc › 2 | 50804-160-01 |
| Openfda › Package ndc › 3 | 41250-598-01 |
| Openfda › Product ndc › 1 | 83324-190 |
| Openfda › Product ndc › 2 | 50804-160 |
| Openfda › Product ndc › 3 | 41250-598 |
| Openfda › Generic name › 1 | TETRAHYDROZOLINE HCL, ZINC SULFATE |
| Openfda › Generic name › 2 | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL |
| Openfda › Generic name › 3 | TETRAHYDROZOLINE HCI, ZINC SULFATE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | TETRAHYDROZOLINE HYDROCHLORIDE |
| Openfda › Substance name › 2 | ZINC SULFATE |
| Openfda › Substance name › 3 | POLYETHYLENE GLYCOL 400 |
| Openfda › Substance name › 4 | PROPYLENE GLYCOL |
| Openfda › Manufacturer name › 1 | Quality Choice |
| Openfda › Manufacturer name › 2 | Geiss, Destin & Dunn, Inc. |
| Openfda › Manufacturer name › 3 | Meijer Distribution, Inc. |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98533 |
| Address 1 | 3420 Pomona Blvd |
| Code info | Lot: a) AC24E01, Exp.: 05/31/26; b) AC24E01, Exp.: 05/31/26; c) AC24E01, Exp.: 05/31/26; d) AC24E01, Exp.: 05/31/26; e) AC24E01, Exp.: 05/31/26; f) AC24E01, Exp.: 05/31/26; g) AC24E01, Exp.: 05/31/26; h)AC24E01, Exp.: 05/31/26; i) AC24E01, Exp.: 05/31/26; j) AC24E01, Exp.: 05/31/26; |
| Postal code | 91768-3236 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 182,424 bottles |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | |
| Center classification date | 20260331 |
Overview
- Recalling FirmK.C. Pharmaceuticals, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the US