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
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。
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。
FDA drug recall enforcement report — D-0008-2027
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) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; b) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; c) RL25D01, Exp.: 04/30/2027; d) RL25E01, Exp.: 05/31/2027; RL25K05, Exp.: 09/30/2027; e) RL25G02, Exp.: 07/31/2027; RL25G03, Exp.: 07/31/2027; RL25G04, Exp.: 07/31/2027; RL25H02, Exp.: 08/30/2028; RL25H03, Exp.: 08/30/2028; RL25H04, Exp.: 08/30/2028; RL25K01, Exp.: 09/30/2027; RL25K02, Exp.: 09/30/2027; RL25K03, Exp.: 09/30/2027; RL25K04, Exp.: 09/30/2027; RL25M01, Exp.: 10/31/2027; RL25M02, Exp.: 10/31/2027; RL25M03, Exp.: 10/31/2027; RL25M04, Exp.: 10/31/2027; RL25N01, Exp.: 11/30/2027; RL25N02, Exp.: 11/30/2027; RL25N04, Exp.: 11/30/2027; f) RL25E01, Exp.: 05/31/2027; RL25G01, Exp.: 07/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25M05, Exp.: 10/31/2027; RL25N03, Exp.: 11/30/2027; g) RL25D01, Exp.: 04/30/2027; RL25E01, Exp.: 05/31/2027; RL25G01, Exp.: 07/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; h) RL25D01, Exp.: 04/30/2027; RL25E01, Exp.: 05/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25M05, Exp.: 10/31/2027; RL25N03, Exp.: 11/30/2027.",
"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": "Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; b) Discount drug mart, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, UPC: 0 93351 03411 4; c) EQUALINE, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 46151 2; d) Colirio Ojo de Aguila, Distributed by Grandall Distributing Co., Inc., Glendale, CA 91204, UPC: 3 48201 01615 5; e) Clear Eyes Redness Relief, ¿ 2025 Dist. by Medtech Products Inc., Tarrytown, NY 10591, UPC 6 78112 25415 6; f) Equate\", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-012-01; g) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Xpect Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC: 130209.",
"product_quantity": "N/A",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260911",
"recall_number": "D-0008-2027",
"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