Drug recalls

Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Ch…

K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility

Class IIOngoingD-0007-2027
Status
Ongoing
City
Pomona
State
CA
Country
United States
Classification
Class II
Product type
Drugs
Event ID
99880
Recalling firm
K.C. Pharmaceuticals, Inc.
Address 1
3420 Pomona Blvd
Address 2
N/A
Postal code
91768-3236
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
E-Mail
Distribution pattern
US Nationwide
Recall number
D-0007-2027
Product quantity
1,025,448 cartons
Reason for recall
Lack of Assurance of Sterility
Recall initiation date
20260911
Center classification date
20261005
Report date
20261014
Product description

Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47011 3; b) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01157 3; c) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-141-01; d) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; e) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71302 5; f) Circle K, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed: by Circle K Stores Inc., UPC: 1 94283 65135 8; g) Lil' DrugStore, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, UPC: 3 66715 68324 3; h) QC, Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-340-15; i) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; j) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-158-05; k) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20073 6; l) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38597 0.

Code info

Lot: a) RG24N02, Exp.: 11/30/2026; b) RG25K04, Exp.: 09/30/2027; c) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K03, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; d) RG24N02, Exp.: 11/30/2026; e) RG25K04, Exp.: 09/30/2027; f) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K03, Exp.: 09/30/2027; RG25K04, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; RG25N03, Exp.: 11/30/2027; g) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K04, Exp.: 09/30/2027; RG25K05, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; h) RG25K05, Exp.: 09/30/2027; i) RG24N02, Exp.: 11/30/2026; RG25K04, Exp.: 09/30/2027; RG25M01, Exp.: 10/31/2027; RG25N02, Exp.: 11/30/2027; RG25N03, Exp.: 11/30/2027; j) RG25E01, Exp.: 05/31/2027; RG25K01, Exp.: 09/30/2027; RG25K02, Exp.: 09/30/2027; RG25K05, Exp.: 09/30/2027; RG25M01, Exp.: 10/31/2027; RG25M02, Exp.: 10/31/2027; RG25P01, Exp.: 12/31/2027; k) RG25D01, Exp.: 04/30/2027; RG25K03, Exp.: 09/30/2027; l) RG24N02, Exp.: 11/30/2026;

Harmonized identifiers (openFDA)
Application number
M018
Brand name
GOODSENSE EYE DROPS ORIGINAL FORMULA, QUALITY CHOICE EYE DROPS REDNESS RELIEF, EQUATE ORIGINAL EYE DROPS
Generic name
TETRAHYDROZOLINE HCL
Manufacturer name
Geiss, Destin & Dunn, Inc., Chain Drug Marketing Assoc., Inc., Walmart, Inc.
Product NDC
50804-141, 83324-340, 79903-158
Product type
HUMAN OTC DRUG
Route
OPHTHALMIC
Substance name
TETRAHYDROZOLINE HYDROCHLORIDE
RxCUI
1052943
SPL ID
47450135-baf6-8cc9-e063-6394a90abbd4, 38d2bc34-c6f1-a09c-e063-6394a90a69e1, 474940b5-b172-6e9c-e063-6394a90a8b01
SPL set ID
9b44de58-6362-3811-e053-2995a90a2f37, 38d2bc34-c6f0-a09c-e063-6394a90a69e1, eb8e5beb-4454-58c2-e053-2a95a90a66e0
Package NDC
50804-141-01, 83324-340-15, 79903-158-05
Is original packager
true
Upc
0180410000156, 0635515903777, 0194346053582, 070038470113, 093351011573, 041220437474, 072036713025, 366715683243, 036800036390, 311917200736, 011110385970
UNII
0YZT43HS7D
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.