Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
Lack of Assurance of Sterility
EYE DROPS Advanced Relief
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
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 NDCs
50804-0130-01
70677-1158-01
83324-0191-14
83817-0963-01
Compare with the code on your package — it is the most precise check available.
Drug: Tetrahydrozoline Category: Eye Drops & Ophthalmic
Product details
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 |
|---|---|---|---|---|
| GoodSense Eye Drops Advanced Relief Moisturizer dextran, polyethylene glycol 400, povidone, tetrahydrozoline HCl NDC 50804-0130 |
POLYETHYLENE GLYCOL 400 1 g/100mL; TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL; POVIDONE 1 g/100mL; DEXTRAN 70 .1 g/100mL | Solution Ophthalmic |
Geiss, Derstin & Dunn, Inc. | 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 |
| Quality Choice Moisturizing Relief Eye Drops Dextran 70, Polyethylene glycol 400, Povidone, Tetrahydrozoline HCl NDC 83324-0191 |
DEXTRAN 70 .1 g/100mL; TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL; POVIDONE 1 g/100mL; POLYETHYLENE GLYCOL 400 1 g/100mL | Solution/ Drops Ophthalmic |
Chain Drug Marketing Association, Inc. | OTC |
| Code Red Eye Drops Redness Relief Polyethylene glycol 400, Tetrahydrozoline HCl NDC 83817-0963 |
POLYETHYLENE GLYCOL 400 1 g/100mL; TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL | Solution/ Drops Ophthalmic |
4 Trees, LLC | OTC |
- Recalling firm
- K.C. Pharmaceuticals, Inc
- NDC code
- 83324-191-14
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0410-2026 · FDA notice
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.
Other Tetrahydrozoline recalls
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Class II · Moderate risk
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Lack of Assurance of Sterility
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Class I · High risk
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Other recalls by K.C. Pharmaceuticals, Inc
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Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
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Lack of Assurance of Sterility
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