FDA 执法报告 D-0005-2027 收录 K.C. Pharmaceuticals 眼部滴剂因无菌保证不足的 II 类召回
FDA drug enforcement D-0005-2027: K.C. Pharmaceuticals, Inc. — Lack of Assurance of Sterility
FDA 执法报告 D-0005-2027 显示 K.C. Pharmaceuticals 因无菌保证不足召回多品牌眼部滴剂，并列为 II 类。
执法报告列出六个品牌标签、具体批号与全美分销范围，可用于核对本次召回的批次信息和分级日期。
FDA drug recall enforcement report — D-0005-2027
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) CM25E02, Exp.: 5/31/2027; CM25M01, Exp.: 10/31/2027; b) CM25E02, Exp.: 5/31/2027; c) CM25C01, Exp.: 3/31/2027; CM25C02, Exp.: 3/31/2027; CM25C03, Exp.: 3/31/2027; CM25E02, Exp.: 5/31/2027; CM25F01, Exp.: 6/30/2027; CM25A02, Exp.: 1/1/2027; CM25B01, Exp.: 2/28/2027; d) CM25B01, Exp.: 2/28/2027; CM25E01, Exp.: 5/31/2027; CM25E02, Exp.: 5/31/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027; e) CM25B01, Exp.: 2/28/2027; CM25F01, Exp.: 6/30/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027; f) CM25B01, Exp.: 2/28/2027; CM25E02, Exp.: 5/31/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027.",
"country": "United States",
"distribution_pattern": "US Nationwide",
"event_id": "99880",
"initial_firm_notification": "E-Mail",
"openfda": {
"application_number": [
"M018"
],
"brand_name": [
"TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE"
],
"generic_name": [
"GLYCERIN, NAPHAZOLINE HYDROCHLORIDE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Target Corporation"
],
"nui": [
"N0000185370",
"N0000175629",
"N0000184306",
"N0000185001",
"M0000728",
"M0009417"
],
"package_ndc": [
"11673-100-01"
],
"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": [
"11673-100"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"rxcui": [
"1235200"
],
"spl_id": [
"0cfa0b71-d377-fa73-e063-6294a90a390e"
],
"spl_set_id": [
"1b26cd3b-4a05-4623-b320-01f22b3106ff"
],
"substance_name": [
"GLYCERIN",
"NAPHAZOLINE HYDROCHLORIDE"
],
"unii": [
"PDC6A3C0OX",
"MZ1131787D"
],
"upc": [
"614299896369",
"072036735898",
"784847575494",
"036800211230",
"311917200750"
]
},
"postal_code": "91768-3236",
"product_description": "Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 89636 9; b) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 73589 8; c) TYSON, MIKE RED EYE DROPS, Distributed by: JBRANDS Distribution, Miami, FL 33009, UPC: 7 84847 57549 4; d) up & up, Distributed by: Target Corporation, Minneapolis, MN 55403, NDC 11673-100-01; e) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 21123 0; f) Walgreens, DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20075 0.",
"product_quantity": "1,435,830 cartons",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260911",
"recall_number": "D-0005-2027",
"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