FDA 召回执法报告 D-0006-2027：K.C. Pharmaceuticals 无菌润滑滴眼液因无菌保证不足被列为 II 类召回
FDA drug enforcement D-0006-2027: K.C. Pharmaceuticals, Inc. — Lack of Assurance of Sterility
openFDA 药品召回执法报告 D-0006-2027 显示，K.C. Pharmaceuticals, Inc. 生产的无菌润滑干眼缓解滴眼液因无菌保证不足（Lack of Assurance of Sterility）被列为 II 类召回。
记录汇总同一事件下多品牌滴眼液的产品、批次与效期，可用于核对受影响包装范围。
FDA drug recall enforcement report — D-0006-2027
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) LT25B01, Exp.: 02/28/2027; b) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; c) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; d) LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027; e) LT25B01, Exp.: 02/28/2027; LT25D01, Exp.: 04/30/2027; LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; LT25M01, Exp.: 10/31/2027; LT25M02, Exp.: 10/31/2027; LT25N01, Exp.: 11/30/2027; LT25N02, Exp.: 11/30/2027; f) LT25B01, Exp.: 02/28/2027; g) LT25M02, Exp.: 10/31/2027; h) LT25B01, Exp.: 02/28/2027; I) LT25B01, Exp.: 02/28/2027; LT25D02, Exp.: 04/30/2027; LT25M02, 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": [
"LEADER DRY EYE RELIEF EYE DROPS",
"ARTIFICIAL TEARS",
"FOSTER AND THRIVE DRY EYE RELIEF"
],
"generic_name": [
"GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400",
"GLYCERIN",
"POLYETHYLENE GLYCOL 400"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"CARDINAL HEALTH 110, LLC. DBA LEADER",
"Geri-Care Pharmaceuticals, Corp",
"Strategic Sourcing Services LLC"
],
"nui": [
"N0000185370",
"N0000175629",
"N0000184306",
"N0000185001",
"M0000728",
"M0009417"
],
"package_ndc": [
"70000-0502-1",
"70000-0502-2",
"57896-181-05",
"70677-1157-1"
],
"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": [
"70000-0502",
"57896-181",
"70677-1157"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"rxcui": [
"259581",
"2360899"
],
"spl_id": [
"5944f7bf-c84b-497f-e063-6394a90aed1f",
"472b069b-4e80-8cb8-e063-6294a90a302b",
"4749275b-6982-4eaf-e063-6394a90aaee9"
],
"spl_set_id": [
"2ded4bda-b3c3-4521-8701-5c8446fd148b",
"7cc437e3-bad9-59be-e053-2991aa0a1da3",
"0018ade9-5856-db6c-e063-6394a90a2ccf"
],
"substance_name": [
"GLYCERIN",
"HYPROMELLOSE, UNSPECIFIED",
"POLYETHYLENE GLYCOL 400",
"HYPROMELLOSES"
],
"unii": [
"PDC6A3C0OX",
"3NXW29V3WO",
"B697894SGQ"
],
"upc": [
"0096295137064",
"0096295137071",
"0357896184056",
"0010939958266",
"867166000004",
"093351011566",
"614299056206",
"041220437412",
"072036713032",
"036800361003"
]
},
"postal_code": "91768-3236",
"product_description": "Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3.",
"product_quantity": "1,327,248 cartons",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260911",
"recall_number": "D-0006-2027",
"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