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openFDA 已分级药品召回执法报告·· 8 天前精选AI 评分72

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

AI 导读

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。

推荐理由

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。

正文 · AI 翻译

FDA 药品召回执法报告 — D-0007-2027

报告发布日期:2026-10-14。这是执法报告日期,不是召回启动日期。

范围:一条已分类的药品召回记录;event_id 可能归组多个产品。无召回编号的未分类记录不在本数据流范围内。本记录不是新闻稿,也不是新的执法认定。

openFDA 数据集每周更新。报告状态不是实时召回状态,不得用于跟踪召回生命周期。以下其他日期保留其各自名称所对应的含义。

完整官方产品记录(包括 openFDA 统一标识符):

{

"address_1": "3420 Pomona Blvd",

"address_2": "N/A",

"center_classification_date": "20261005",

"city": "Pomona",

"classification": "Class II",

"code_info": "批号:a) RG24N02,有效期:11/30/2026;b) RG25K04,有效期:09/30/2027;c) RG24N02,有效期:11/30/2026;RG25D01,有效期:04/30/2027;RG25D02,有效期:04/30/2027;RG25K02,有效期:09/30/2027;RG25K03,有效期:09/30/2027;RG25N02,有效期:11/30/2027;d) RG24N02,有效期:11/30/2026;e) RG25K04,有效期:09/30/2027;f) RG24N02,有效期:11/30/2026;RG25D01,有效期:04/30/2027;RG25D02,有效期:04/30/2027;RG25K03,有效期:09/30/2027;RG25K04,有效期:09/30/2027;RG25N02,有效期:11/30/2027;RG25N03,有效期:11/30/2027;g) RG24N02,有效期:11/30/2026;RG25D01,有效期:04/30/2027;RG25D02,有效期:04/30/2027;RG25K02,有效期:09/30/2027;RG25K04,有效期:09/30/2027;RG25K05,有效期:09/30/2027;RG25N02,有效期:11/30/2027;h) RG25K05,有效期:09/30/2027;i) RG24N02,有效期:11/30/2026;RG25K04,有效期:09/30/2027;RG25M01,有效期:10/31/2027;RG25N02,有效期:11/30/2027;RG25N03,有效期:11/30/2027;j) RG25E01,有效期:05/31/2027;RG25K01,有效期:09/30/2027;RG25K02,有效期:09/30/2027;RG25K05,有效期:09/30/2027;RG25M01,有效期:10/31/2027;RG25M02,有效期:10/31/2027;RG25P01,有效期:12/31/2027;k) RG25D01,有效期:04/30/2027;RG25K03,有效期:09/30/2027;l) RG24N02,有效期: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": "无菌滴眼液,ORIGINAL,盐酸四氢唑啉 0.05% 缓解红眼 ¿ 速效配方)产品规格:0.5 液量盎司(15 mL);a) Best Choice,由以下公司自豪经销: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 无菌滴眼液,经销方:Geiss, Destin & Dunn, Inc.,A Perrigo Company,Peachtree City, GA 30269,NDC 50804-141-01;d) H.E.B Dry Eye 滴眼液,以自豪与关怀为 H-E-B 制造,SAN ANTONIO, TX 78204,UPC 0 41220 43747 4;e) Harris Teeter,由以下公司自豪经销:HARRIS TEETER, LLC,MATTHEWS, NC 28105,UPC:0 72036 71302 5;f) Circle K,产品制造方:Lil' Drug Store Products, Inc.,Cedar Rapids, IA 52404,自豪经销方:Circle K Stores Inc.,UPC:1 94283 65135 8;g) Lil' DrugStore,产品制造方:Lil' Drug Store Products, Inc.,9300 Earhart Lane SW, Cedar Rapids, IA 52404,UPC:3 66715 68324 3;h) QC,Quality Choice,经销方 CDMA Inc,Novi, MI,NDC 83324-340-15;i) TopCare health,经销方 TOPCO ASSOCIATES LLC,ELKGROVE VILLAGE, IL 60007,UPC 0 36800 03639 0;j) Equate\",经销方 WALMART INC.,Bentonville, AR 72716,NDC 79903-158-05;k) Walgreens,经销方:WALGREEN CO.,200 WILMOT RD, DEERFIELD, IL 60015,UPC 3 11917 20073 6;l) Kroger,经销方 THE KROGER CO.,CINCINNATI, OHIO 45202,UPC 0 11110 38597 0。",

"product_quantity": "1,025,448 箱",

"product_type": "药品",

"reason_for_recall": "无菌性缺乏保证",

"recall_initiation_date": "20260911",

"recall_number": "D-0007-2027",

"recalling_firm": "K.C. Pharmaceuticals, Inc.",

"report_date": "20261014",

"state": "CA",

"status": "进行中",

"voluntary_mandated": "自愿:企业发起"

}

来源:openFDA 已分级药品召回执法报告 · api.fda.gov