FDA 执法报告 D-0004-2027 记录 K.C. Pharmaceuticals 滴眼液无菌保证不足的 II 类召回
FDA drug enforcement D-0004-2027: K.C. Pharmaceuticals, Inc. — Lack of Assurance of Sterility
openFDA 执法报告 D-0004-2027 记录 K.C. Pharmaceuticals 因无菌保证不足自愿召回多品牌无菌滴眼液，FDA 将其列为 II 类。
记录列出无菌保证不足召回的类别、批次与全国分销范围，可用于核对同一事件下多品牌滴眼液的产品归属。
FDA 药品召回执法报告 — D-0004-2027
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。没有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": "Lot: a) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01, Exp.: 1/1/2027.",
"country": "United States",
"distribution_pattern": "US Nationwide",
"event_id": "99880",
"initial_firm_notification": "E-Mail",
"openfda": {
"application_number": [
"M018"
],
"brand_name": [
"LEADER ADVANCED RELIEF EYE DROPS",
"GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER",
"MEDICS CHOICE EYE DROPS ADVANCED",
"FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS",
"QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS"
],
"generic_name": [
"DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL",
"DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL",
"TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE",
"POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Cardinal Health",
"Geiss, Derstin & Dunn, Inc.",
"KC Pharmaceuticals, Inc.",
"Strategic Sourcing Services LLC",
"Chain Drug Marketing Association, Inc."
],
"nui": [
"N0000184175",
"N0000009361",
"N0000010288"
],
"package_ndc": [
"70000-0456-1",
"50804-130-01",
"55651-025-01",
"70677-1158-1",
"83324-191-14"
],
"pharm_class_epc": [
"Plasma Volume Expander [EPC]"
],
"pharm_class_moa": [
"Osmotic Activity [MoA]"
],
"pharm_class_pe": [
"Increased Intravascular Volume [PE]"
],
"product_ndc": [
"70000-0456",
"50804-130",
"55651-025",
"70677-1158",
"83324-191"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"rxcui": [
"996202",
"996209"
],
"spl_id": [
"4ccce313-8eec-8a62-e063-6394a90aa128",
"47450d1c-db32-92cd-e063-6394a90a0703",
"4748d5b2-f2f1-e88b-e063-6394a90af39a",
"474922b2-773c-4cff-e063-6394a90a6b3a",
"4749597d-57d8-92b6-e063-6294a90ab574"
],
"spl_set_id": [
"5c5d6c13-9b51-48f0-8627-b60b0f707fd3",
"9b34de99-13df-201a-e053-2a95a90ae559",
"ab906fd8-265c-4359-a920-d626366e245c",
"0019cd99-b245-2ffc-e063-6294a90a9f27",
"1fb81759-5931-59c8-e063-6294a90a2277"
],
"substance_name": [
"DEXTRAN 70",
"POLYETHYLENE GLYCOL 400",
"POVIDONE",
"TETRAHYDROZOLINE HYDROCHLORIDE"
],
"unii": [
"7SA290YK68",
"B697894SGQ",
"FZ989GH94E",
"0YZT43HS7D"
],
"upc": [
"0096295136470",
"0180410000194",
"0095072012518",
"0010939958273",
"0635515903760",
"041163253926",
"041220437450",
"184125000180",
"041415067769",
"036800036413"
]
},
"postal_code": "91768-3236",
"product_description": "无菌滴眼液 Advanced Relief（dextran 70，0.1%，polyethylene glycol 400 1% 和 tetrahydrozoline HCl 0.05%），0.5 FL OZ（15 mL）瓶装，无菌；a) LEADER，DISTRIBUTED BY CARDINAL HEALTH，DUBLIN, OHIO 43017，www.myleader.com，NDC 70000-0456-1；b) Equaline，DISTRIBUTED BY: UNFI，PROVIDENCE, RI 02908 UPC 0 41163 25392 6；c) GoodSense，Distributed By: Geiss, Destin& Dunn, Inc.，A Perrigo Company，Peachtree City, GA 30269，www.PerrigoDirect.com，NDC 50804-130-01；d) H.E.B A.C. Eye Drops，MADE WITH PRIDE & CARE FOR H-E-B，SAN ANTONIO, TX 78204，UPC 0 41220 43745 0；e) Medic'c Choice，Manufactured by KC Pharmaceuticals, Inc.，Pomona, CA 91768，NDC 55651-025-01；f) Foster & Thrive，Distributed by: McKesson Corp.，via Strategic Sourcing Services LLC，Memphis, TN 38141，NDC 70677-1158-1；g) Colirio Manzanill A+，Distributed by: PRO-MEX，P.O Box 63-0716，Miami , FL 33163，UPC: 1 84125 00018 0；h) P，DISTRIBUTED BY PUBLIX SUPER MARKETS, INC，3300 PUBLIX CORPORATE PARKWAY，LAKELAND, FL 33811，UPC 0 41415 06776 9；I) QC-Quality Choice，Distributed by: CDMA, Inc.，Novi, MI 48375，NDC 83324-191-14；J) TopCare health，DISTRIBUTED BY TOPCO ASSOCIATES LLC，ELKGROVE VILLAGE, IL 60007，UPC 0 36800 03641 3。",
"product_quantity": "208,896 箱",
"product_type": "药品",
"reason_for_recall": "无菌性缺乏保证",
"recall_initiation_date": "20260911",
"recall_number": "D-0004-2027",
"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