Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Sterile EYE DROPS AC (Tetrahydrozoline HCL, Zinc Sulfate)
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
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 NDCs
41250-0598-01
50804-0160-01
83324-0190-14
Compare with the code on your package — it is the most precise check available.
Drug: Zinc 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 |
|---|---|---|---|---|
| Meijer Seasonal Itching and Redness Relief Tetrahydrozoline HCI, Zinc sulfate NDC 41250-0598 |
TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL; ZINC SULFATE .25 g/100mL | Solution/ Drops Ophthalmic |
Meijer Distribution, Inc. | OTC |
| GoodSense Ultra Lubricant Eye Drops polyethylene glycol 400, propylene glycol NDC 50804-0160 |
PROPYLENE GLYCOL .3 g/100mL; POLYETHYLENE GLYCOL 400 .4 g/100mL | Solution Ophthalmic |
Geiss, Destin & Dunn, Inc. | OTC |
| Quality Choice Eye Drops Irritation Relief Tetrahydrozoline HCl, Zinc sulfate NDC 83324-0190 |
TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL; ZINC SULFATE .25 g/100mL | Solution/ Drops Ophthalmic |
Quality Choice | OTC |
- Recalling firm
- K.C. Pharmaceuticals, Inc
- NDC code
- 83324-190-14
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0409-2026 · 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.
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