FDA 执法报告将 K.C. Pharmaceuticals 眼用滴剂召回 D-0009-2027 列为 II 级，原因为无菌保证不足
FDA drug enforcement D-0009-2027: K.C. Pharmaceuticals, Inc. — Lack of Assurance of Sterility
FDA 执法报告 D-0009-2027 将 K.C. Pharmaceuticals 的无菌超润滑滴眼液召回定为 II 级，原因为无菌保证不足。记录涉及 LEADER、exchange select、Good Sense、Walgreens 四种包装配置，批号为 SU25B01、SU25N01、SU25N02，合计 163,008 箱，全美分销。
记录列出眼用滴剂各包装配置对应的批号与全美分销范围，可用于核对无菌保证缺陷召回所涉产品的具体边界。
FDA 药品召回执行报告 — D-0009-2027
报告发布日期：2026-10-14。这是执行报告日期，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) SU25B01, Exp.: 02/28/2027; b) SU25N01, Exp.: 11/30/2027; c) SU25B01, Exp.: 02/28/2027; SU25N01, Exp.: 11/30/2027; SU25N02, Exp.: 11/30/2027; d) SU25B01, Exp.: 02/28/2027.",
"country": "United States",
"distribution_pattern": "US Nationwide",
"event_id": "99880",
"initial_firm_notification": "E-Mail",
"openfda": {
"application_number": [
"M018"
],
"brand_name": [
"LEADER ULTRA LUBRICATING EYE DROPS",
"GOODSENSE ULTRA LUBRICANT EYE DROPS"
],
"generic_name": [
"POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Cardinal Health",
"Geiss, Destin & Dunn, Inc."
],
"package_ndc": [
"70000-0457-1",
"70000-0457-2",
"50804-160-01",
"1429905619"
],
"product_ndc": [
"70000-0457",
"50804-160"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"rxcui": [
"477589"
],
"spl_id": [
"4ccccdc5-a8f7-6d26-e063-6394a90a8795",
"474511c4-1fbd-70b8-e063-6294a90af8e8"
],
"spl_set_id": [
"d7f011a2-05ba-47c3-9519-d31602e105c7",
"9b45ebb5-c43b-c9fb-e053-2a95a90a3411"
],
"substance_name": [
"POLYETHYLENE GLYCOL 400",
"PROPYLENE GLYCOL"
],
"unii": [
"B697894SGQ",
"6DC9Q167V3"
],
"upc": [
"0096295137101",
"0846036008210",
"614299056190",
"311917201672"
]
},
"postal_code": "91768-3236",
"product_description": "Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 1429905619 0; c) Good Sense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, NDC 50804-160-01; d) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20167 2.",
"product_quantity": "163,008 cartons",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260911",
"recall_number": "D-0009-2027",
"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