EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetr...
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01.
Affected Products
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) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Pomona |
| State | CA |
| Openfda › Nui › 1 | N0000184175 |
| Openfda › Nui › 2 | N0000009361 |
| Openfda › Nui › 3 | N0000010288 |
| Openfda › Upc › 1 | 0635515903760 |
| Openfda › Upc › 2 | 0010939958273 |
| Openfda › Upc › 3 | 0180410000194 |
| Openfda › Upc › 4 | 0095072025112 |
| Openfda › Upc › 5 | 311917200743 |
| Openfda › Upc › 6 | 050428435441 |
| Openfda › Upc › 7 | 093351011559 |
| Openfda › Upc › 8 | 036800036413 |
| Openfda › Upc › 9 | 095072025563 |
| Openfda › Unii › 1 | 7SA290YK68 |
| Openfda › Unii › 2 | B697894SGQ |
| Openfda › Unii › 3 | FZ989GH94E |
| Openfda › Unii › 4 | 0YZT43HS7D |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui › 1 | 996202 |
| Openfda › Rxcui › 2 | 996209 |
| Openfda › Spl id › 1 | 4749597d-57d8-92b6-e063-6294a90ab574 |
| Openfda › Spl id › 2 | 474922b2-773c-4cff-e063-6394a90a6b3a |
| Openfda › Spl id › 3 | 47450d1c-db32-92cd-e063-6394a90a0703 |
| Openfda › Spl id › 4 | 2dc61a4e-5308-5145-e063-6294a90a06d7 |
| Openfda › Brand name › 1 | QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS |
| Openfda › Brand name › 2 | FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS |
| Openfda › Brand name › 3 | GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER |
| Openfda › Brand name › 4 | CODE RED EYE DROPS REDNESS RELIEF |
| Openfda › Spl set id › 1 | 1fb81759-5931-59c8-e063-6294a90a2277 |
| Openfda › Spl set id › 2 | 0019cd99-b245-2ffc-e063-6294a90a9f27 |
| Openfda › Spl set id › 3 | 9b34de99-13df-201a-e053-2a95a90ae559 |
| Openfda › Spl set id › 4 | 0aa08018-cc2d-d947-e063-6394a90a914a |
| Openfda › Package ndc › 1 | 83324-191-14 |
| Openfda › Package ndc › 2 | 70677-1158-1 |
| Openfda › Package ndc › 3 | 50804-130-01 |
| Openfda › Package ndc › 4 | 83817-963-01 |
| Openfda › Product ndc › 1 | 83324-191 |
| Openfda › Product ndc › 2 | 70677-1158 |
| Openfda › Product ndc › 3 | 50804-130 |
| Openfda › Product ndc › 4 | 83817-963 |
| Openfda › Generic name › 1 | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL |
| Openfda › Generic name › 2 | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL |
| Openfda › Generic name › 3 | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class pe | Increased Intravascular Volume [PE] |
| Openfda › Substance name › 1 | DEXTRAN 70 |
| Openfda › Substance name › 2 | POLYETHYLENE GLYCOL 400 |
| Openfda › Substance name › 3 | POVIDONE |
| Openfda › Substance name › 4 | TETRAHYDROZOLINE HYDROCHLORIDE |
| Openfda › Pharm class epc | Plasma Volume Expander [EPC] |
| Openfda › Pharm class moa | Osmotic Activity [MoA] |
| Openfda › Manufacturer name › 1 | Chain Drug Marketing Association, Inc. |
| Openfda › Manufacturer name › 2 | Strategic Sourcing Services LLC |
| Openfda › Manufacturer name › 3 | Geiss, Derstin & Dunn, Inc. |
| Openfda › Manufacturer name › 4 | 4 Trees, LLC |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98533 |
| Address 1 | 3420 Pomona Blvd |
| Code info | Lot: a) AR24D01, Exp.: 04/30/26; AR24G01, AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; b) AR24D01, Exp.: 04/30/26; AR24G01, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; c) AR24D01, Exp.: 04/30/26; AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; d) AR24G02, Exp.: 07/31/26; e) AR24G02, Exp.: 07/31/26; f) AR24G02, Exp.: 07/31/26; g) AR24M01, Exp.: 10/31/26, h) AR24G01, Exp.: 07/31/26; AR24M01, Exp.:10/31/26; I) AR24M01, Exp.:10/31/26; j) AR24D01, Exp.: 04/30/26. |
| Postal code | 91768-3236 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 303,216 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