Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distribute...
FDA Drug Recall #D-0897-2023 — Class II — June 13, 2023
Recall Summary
| Recall Number | D-0897-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 13, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | K.C. Pharmaceuticals, Inc |
| Location | Pomona, CA |
| Product Type | Drugs |
| Quantity | 341,568 bottles |
Product Description
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) 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; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; e) Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01; f) 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; g) 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; h) 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, i) Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1; j) REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05; k) 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; l) Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7; m) CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3; n) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; o) 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; p) Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3
Reason for Recall
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot #: a) RG21F01, Exp: 6/30/2023; b) RG21F01, Exp: 6/30/2023; c) RG21F01, Exp: 6/30/2023; d) RG21F01, RG21F02, Exp 6/30/2023; e) RG21F02, RG21F03, Exp 6/30/2023; f) RG21F02, Exp 6/30/2023; g) RG21F02, Exp 6/30/2023; h) RG21F02, Exp 6/30/2023; i) RG21F02, Exp 6/30/2023; j) RG21F02, Exp 6/30/2023; k) RG21F02, Exp 6/30/2023; l) RG21F02, Exp 6/30/2023; m) RG21F03, Exp 6/30/2023; n) RG21F03, Exp 6/30/2023; o) RG21F03, Exp 6/30/2023; p) RG21F03, Exp 6/30/2023
Other Recalls from K.C. Pharmaceuticals, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0898-2023 | Class II | Dry Eye Relief Lubricant Eye Drops, (Glycerin 0... | Jun 13, 2023 |
Frequently Asked Questions
cGMP stands for Current Good Manufacturing Practice — the FDA's regulations governing drug manufacturing quality. A cGMP recall means the company failed to follow required manufacturing standards. This could involve inadequate testing, poor environmental controls, documentation failures, or process deviations. cGMP recalls do not always mean the product is directly harmful — in many cases, quality records are insufficient to confirm the product meets specifications. However, the FDA requires a recall because without proper documentation, product quality cannot be assured. These are often Class II or Class III recalls.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.