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openFDA 已分级药品召回执法报告·· 8 天前精选AI 评分77

FDA 执法报告 D-0008-2027:K.C. Pharmaceuticals 因无菌保证不足召回多品牌无菌滴眼液

FDA drug enforcement D-0008-2027: K.C. Pharmaceuticals, Inc. — Lack of Assurance of Sterility

AI 导读

openFDA 执法报告 D-0008-2027 显示,K.C. Pharmaceuticals, Inc. 因缺乏无菌保证(Lack of Assurance of Sterility)自愿召回多品牌无菌滴眼液,产品在全美分销,分类为 Class II。

推荐理由

记录列出召回分类、批号清单与全美分销范围,便于对照产品标识核对本次无菌保证问题涉及的批次。

正文 · AI 翻译

FDA 药品召回执法报告 — D-0008-2027

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(含 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) RL25D01,有效期:2027/04/30;RL25G01,有效期:2027/07/31;RL25K05,有效期:2027/09/30;RL25N03,有效期:2027/11/30;b) RL25D01,有效期:2027/04/30;RL25G01,有效期:2027/07/31;c) RL25D01,有效期:2027/04/30;d) RL25E01,有效期:2027/05/31;RL25K05,有效期:2027/09/30;e) RL25G02,有效期:2027/07/31;RL25G03,有效期:2027/07/31;RL25G04,有效期:2027/07/31;RL25H02,有效期:2028/08/30;RL25H03,有效期:2028/08/30;RL25H04,有效期:2028/08/30;RL25K01,有效期:2027/09/30;RL25K02,有效期:2027/09/30;RL25K03,有效期:2027/09/30;RL25K04,有效期:2027/09/30;RL25M01,有效期:2027/10/31;RL25M02,有效期:2027/10/31;RL25M03,有效期:2027/10/31;RL25M04,有效期:2027/10/31;RL25N01,有效期:2027/11/30;RL25N02,有效期:2027/11/30;RL25N04,有效期:2027/11/30;f) RL25E01,有效期:2027/05/31;RL25G01,有效期:2027/07/31;RL25H01,有效期:2028/08/30;RL25K05,有效期:2027/09/30;RL25M05,有效期:2027/10/31;RL25N03,有效期:2027/11/30;g) RL25D01,有效期:2027/04/30;RL25E01,有效期:2027/05/31;RL25G01,有效期:2027/07/31;RL25H01,有效期:2028/08/30;RL25K05,有效期:2027/09/30;RL25N03,有效期:2027/11/30;h) RL25D01,有效期:2027/04/30;RL25E01,有效期:2027/05/31;RL25H01,有效期:2028/08/30;RL25K05,有效期:2027/09/30;RL25M05,有效期:2027/10/31;RL25N03,有效期:2027/11/30。",

"country": "United States",

"distribution_pattern": "US Nationwide",

"event_id": "99880",

"initial_firm_notification": "E-Mail",

"openfda": {

"application_number": [

"M018"

],

"brand_name": [

"LEADER EYE DROPS REDNESS RELIEF",

"EQUATE REDNESS AND DRY EYE RELIEF EYE DROPS"

],

"generic_name": [

"GLYCERIN, NAPHAZOLINE HYDROCHLORIDE",

"GLYCERIN, NAPHAZOLINE HCL"

],

"is_original_packager": [

true

],

"manufacturer_name": [

"Cardinal Health",

"Wal-Mart Stores, Inc."

],

"nui": [

"N0000185370",

"N0000175629",

"N0000184306",

"N0000185001",

"M0000728",

"M0009417"

],

"package_ndc": [

"70000-0010-1",

"70000-0010-2",

"79903-012-01"

],

"pharm_class_cs": [

"Allergens [CS]",

"Glycerol [CS]"

],

"pharm_class_epc": [

"Non-Standardized Chemical Allergen [EPC]"

],

"pharm_class_pe": [

"Increased Histamine Release [PE]",

"Cell-mediated Immunity [PE]",

"Increased IgG Production [PE]"

],

"product_ndc": [

"70000-0010",

"79903-012"

],

"product_type": [

"HUMAN OTC DRUG"

],

"route": [

"OPHTHALMIC"

],

"rxcui": [

"1046700"

],

"spl_id": [

"5b11dcac-4699-9567-e063-6294a90aadf3",

"474945a2-ec0b-0a68-e063-6294a90a1088"

],

"spl_set_id": [

"aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a",

"ae228018-9238-2cbd-e053-2995a90a8d99"

],

"substance_name": [

"GLYCERIN",

"NAPHAZOLINE HYDROCHLORIDE"

],

"unii": [

"PDC6A3C0OX",

"MZ1131787D"

],

"upc": [

"0096295137620",

"0096295137637",

"0681131395342",

"093351034114",

"041163461512",

"348201016155",

"678112254156",

"311917177410"

]

},

"postal_code": "91768-3236",

"product_description": "无菌滴眼液 缓解红眼(甘油 0.25%,盐酸萘甲唑啉 0.02% 润滑剂 | 缓解红眼)(缓解干涩、灼烧和刺激),0.5 液量盎司(15 mL);a) LEADER,由 CARDINAL HEALTH 分销,DUBLIN, OHIO 43017,www.myleader.com,NDC 70000-0010-1;b) Discount drug mart,分销商:Discount Drug Mart,211 Commerce Drive, Medina, OH 44256,UPC: 0 93351 03411 4;c) EQUALINE,分销商:UNFI,PROVIDENCE, RI 02908 UPC 0 41163 46151 2;d) Colirio Ojo de Aguila,分销商 Grandall Distributing Co., Inc.,Glendale, CA 91204,UPC: 3 48201 01615 5;e) Clear Eyes 缓解红眼,¿ 2025 由 Medtech Products Inc. 分销,Tarrytown, NY 10591,UPC 6 78112 25415 6;f) Equate\",由 WALMART INC. 分销,Bentonville, AR 72716,NDC 79903-012-01;g) Walgreens,分销商:WALGREEN CO.,200 WILMOT RD, DEERFIELD, IL 60015,UPC 3 11917 17741 0;h) Xpect 工业眼部舒缓,分销商:Cintas Corp.,Mason, OH 45040,UPC: 130209。",

"product_quantity": "不适用",

"product_type": "药品",

"reason_for_recall": "无菌性缺乏保证",

"recall_initiation_date": "20260911",

"recall_number": "D-0008-2027",

"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