FDA 执法报告 D-0007-2027 将 K.C. Pharmaceuticals 四氢唑啉滴眼液召回列为二级
FDA drug enforcement D-0007-2027: K.C. Pharmaceuticals, Inc. — Lack of Assurance of Sterility
FDA 执法报告 D-0007-2027 将 K.C. Pharmaceuticals 的四氢唑啉 HCl 0.05% 滴眼液召回列为二级，原因为无菌保证不足。
记录列出了四氢唑啉滴眼液多个批次因无菌保证不足被列为二级召回的批号与有效期，可用于核对涉及的产品和包装范围。
FDA drug recall enforcement report — D-0007-2027
Report issued: 2026-10-14. This is the enforcement report date, not the recall initiation date.
Scope: one classified drug product recall record; event_id may group multiple products. Unclassified records without recall numbers are outside this stream. This record is not a press release or a new enforcement finding.
The openFDA dataset is updated weekly. Report status is not a live recall status and must not be used to track the recall lifecycle. Other dates below retain their named meanings.
Complete official product record (including openFDA harmonized identifiers):
{
"address_1": "3420 Pomona Blvd",
"address_2": "N/A",
"center_classification_date": "20261005",
"city": "Pomona",
"classification": "Class II",
"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;",
"country": "United States",
"distribution_pattern": "US Nationwide",
"event_id": "99880",
"initial_firm_notification": "E-Mail",
"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"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Geiss, Destin & Dunn, Inc.",
"Chain Drug Marketing Assoc., Inc.",
"Walmart, Inc."
],
"package_ndc": [
"50804-141-01",
"83324-340-15",
"79903-158-05"
],
"product_ndc": [
"50804-141",
"83324-340",
"79903-158"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"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"
],
"substance_name": [
"TETRAHYDROZOLINE HYDROCHLORIDE"
],
"unii": [
"0YZT43HS7D"
],
"upc": [
"0180410000156",
"0635515903777",
"0194346053582",
"070038470113",
"093351011573",
"041220437474",
"072036713025",
"366715683243",
"036800036390",
"311917200736",
"011110385970"
]
},
"postal_code": "91768-3236",
"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.",
"product_quantity": "1,025,448 cartons",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260911",
"recall_number": "D-0007-2027",
"recalling_firm": "K.C. Pharmaceuticals, Inc.",
"report_date": "20261014",
"state": "CA",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov