FDA 召回执法报告 D-0002-2027 收录 K.C. Pharmaceuticals 人工泪液无菌保证不足的 Class II 召回
FDA drug enforcement D-0002-2027: K.C. Pharmaceuticals, Inc. — Lack of Assurance of Sterility
openFDA 药品召回执法报告 D-0002-2027 收录 K.C. Pharmaceuticals 人工泪液无菌润滑滴眼液召回，分级为 Class II，记录状态为 Ongoing。
记录列出了同一事件下多个经销品牌人工泪液的批次与有效期，可用于核对本次召回的覆盖范围。
FDA drug recall enforcement report — D-0002-2027
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) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; AT25K02, Exp.: 9/30/2027; e) AT25B01, Exp.: 2/28/2027; f) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; g) AT25B01, Exp.: 2/28/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; h) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; I) AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; J) AT24N01, 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": [
"LEADER ARTIFICIAL TEARS 15 ML",
"GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS",
"GOOD SENSE ARTIFICIAL TEARS",
"ARTIFICIAL TEARS",
"QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS"
],
"generic_name": [
"POLYVINYL ALCOHOL, POVIDONE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Cardinal Health",
"AmerisourceBergen",
"Geiss, Destin & Dunn, Inc.",
"KC Pharmaceuticals, Inc.",
"Chain Drug Marketing Association, Inc."
],
"package_ndc": [
"70000-0011-1",
"24385-006-05",
"50804-110-01",
"55651-008-01",
"83324-189-14"
],
"product_ndc": [
"70000-0011",
"24385-006",
"50804-110",
"55651-008",
"83324-189"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"rxcui": [
"598050"
],
"spl_id": [
"5b120e34-0a0e-e1ae-e063-6294a90a15bc",
"5739a45b-5bf7-5db8-e063-6394a90a7ffc",
"47450941-e9fd-623c-e063-6294a90a940b",
"4748d0f4-e97c-a0c1-e063-6394a90ac311",
"47494778-349f-6448-e063-6294a90a3c34"
],
"spl_set_id": [
"8cccc589-3a8e-baad-e053-2a95a90ab8c7",
"ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f",
"9b243301-2e4b-5706-e053-2995a90a9b90",
"eb6eb6c4-1609-407b-84e4-c7509811f3c0",
"1f669655-4bc7-0175-e063-6294a90a305a"
],
"substance_name": [
"POLYVINYL ALCOHOL, UNSPECIFIED",
"POVIDONE",
"POVIDONE, UNSPECIFIED",
"POLYVINYL ALCOHOL"
],
"unii": [
"532B59J990",
"FZ989GH94E"
],
"upc": [
"0096295137644",
"0087701104060",
"0180410000163",
"0095072015519",
"0635515992238",
"070038470083",
"041415009769",
"036800093317",
"311917065038",
"011110386007"
]
},
"postal_code": "91768-3236",
"product_description": "Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7.",
"product_quantity": "505,896 cartons",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260911",
"recall_number": "D-0002-2027",
"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