Reported Jul 19, 2023 · Ongoing
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original…
K.C. Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: K.C. Pharmaceuticals, Inc · 3215 Producer Way · Pomona, CA · 91768-3916
Is this the product you have?
16 of 16 products
| # | Product as published |
|---|---|
| 1 | Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5 |
| 2 | Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5 |
| 3 | sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 16733 0, NDC 49348-037-29 |
| 4 | TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0 |
| 5 | Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01 |
| 6 | sterile eye drops, Circle K, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8 |
| 7 | Sterile Eye Drops, Regular Formula, Lil Drug Store, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404; UPC 3 66715 68324 3 |
| 8 | Tetrahydrozoline Ophthalmic Solution, Rugby, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, UPC 3 05361 21794 5, NDC 0536-1217-94 |
| 9 | Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1 |
| 10 | REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05 |
| 11 | Eye Drops, Original Formula, Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, UPC 0 87701 14975 7, NDC 24385-075-05 |
| 12 | Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7 |
| 13 | CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3 |
| 14 | H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4 |
| 15 | redness relief, Original Redness Reliever Eye Drops, meijer, DIST. BY MEIJER DISTRIBUTION INC., GRAND RAPIDS, MI 49544, UPC 0 41250 82916 4, NDC 41250-814-01 |
| 16 | Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3 |
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 1 RG21F01, Exp: 6/30/2023 2 RG21F01, Exp: 6/30/2023 3 RG21F01, Exp: 6/30/2023 4 RG21F01, RG21F02, Exp 6/30/2023 5 RG21F02, RG21F03, Exp 6/30/2023 6 RG21F02, Exp 6/30/2023 7 RG21F02, Exp 6/30/2023 8 RG21F02, Exp 6/30/2023 9 RG21F02, Exp 6/30/2023 10 RG21F02, Exp 6/30/2023 11 RG21F02, Exp 6/30/2023 12 RG21F02, Exp 6/30/2023 13 RG21F03, Exp 6/30/2023 14 RG21F03, Exp 6/30/2023 15 RG21F03, Exp 6/30/2023 16 RG21F03, Exp 6/30/2023 - Amount recalled
- 341,568 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
This product could cause temporary or reversible health problems — stop using it.
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