Home/Recalls/FDA-D-0410-2026
FDA DrugsClass II

EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetr...

Published: April 8, 2026Recall ID: D-0410-2026Category: drugsCountry: US

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

FieldValue
CityPomona
StateCA
Openfda › Nui › 1N0000184175
Openfda › Nui › 2N0000009361
Openfda › Nui › 3N0000010288
Openfda › Upc › 10635515903760
Openfda › Upc › 20010939958273
Openfda › Upc › 30180410000194
Openfda › Upc › 40095072025112
Openfda › Upc › 5311917200743
Openfda › Upc › 6050428435441
Openfda › Upc › 7093351011559
Openfda › Upc › 8036800036413
Openfda › Upc › 9095072025563
Openfda › Unii › 17SA290YK68
Openfda › Unii › 2B697894SGQ
Openfda › Unii › 3FZ989GH94E
Openfda › Unii › 40YZT43HS7D
Openfda › RouteOPHTHALMIC
Openfda › Rxcui › 1996202
Openfda › Rxcui › 2996209
Openfda › Spl id › 14749597d-57d8-92b6-e063-6294a90ab574
Openfda › Spl id › 2474922b2-773c-4cff-e063-6394a90a6b3a
Openfda › Spl id › 347450d1c-db32-92cd-e063-6394a90a0703
Openfda › Spl id › 42dc61a4e-5308-5145-e063-6294a90a06d7
Openfda › Brand name › 1QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS
Openfda › Brand name › 2FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS
Openfda › Brand name › 3GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER
Openfda › Brand name › 4CODE RED EYE DROPS REDNESS RELIEF
Openfda › Spl set id › 11fb81759-5931-59c8-e063-6294a90a2277
Openfda › Spl set id › 20019cd99-b245-2ffc-e063-6294a90a9f27
Openfda › Spl set id › 39b34de99-13df-201a-e053-2a95a90ae559
Openfda › Spl set id › 40aa08018-cc2d-d947-e063-6394a90a914a
Openfda › Package ndc › 183324-191-14
Openfda › Package ndc › 270677-1158-1
Openfda › Package ndc › 350804-130-01
Openfda › Package ndc › 483817-963-01
Openfda › Product ndc › 183324-191
Openfda › Product ndc › 270677-1158
Openfda › Product ndc › 350804-130
Openfda › Product ndc › 483817-963
Openfda › Generic name › 1DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL
Openfda › Generic name › 2POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL
Openfda › Generic name › 3DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL
Openfda › Product typeHUMAN OTC DRUG
Openfda › Pharm class peIncreased Intravascular Volume [PE]
Openfda › Substance name › 1DEXTRAN 70
Openfda › Substance name › 2POLYETHYLENE GLYCOL 400
Openfda › Substance name › 3POVIDONE
Openfda › Substance name › 4TETRAHYDROZOLINE HYDROCHLORIDE
Openfda › Pharm class epcPlasma Volume Expander [EPC]
Openfda › Pharm class moaOsmotic Activity [MoA]
Openfda › Manufacturer name › 1Chain Drug Marketing Association, Inc.
Openfda › Manufacturer name › 2Strategic Sourcing Services LLC
Openfda › Manufacturer name › 3Geiss, Derstin & Dunn, Inc.
Openfda › Manufacturer name › 44 Trees, LLC
Openfda › Application numberM018
Openfda › Is original packagertrue
Event id98533
Address 13420 Pomona Blvd
Code infoLot: 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 code91768-3236
Report date20260408
Product typeDrugs
Product quantity303,216 bottles
Reason for recallLack of Assurance of Sterility
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260303
Initial firm notificationE-Mail
Center classification date20260331

Overview

  • Recalling FirmK.C. Pharmaceuticals, Inc
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide in the US
Official Agency Alert