FDA 召回执法报告 D-0874-2026：Aurolab Trust 召回无菌保证不足的 FOCUS PI 羟丙甲纤维素滴眼液，分级 Class II
FDA drug enforcement D-0874-2026: Aurolab Trust — Lack of Assurance of Sterility
FDA 药品召回执法报告 D-0874-2026 显示，Aurolab Trust 因无菌保证不足自愿召回 FOCUS PI 羟丙甲纤维素 0.7% 滴眼液，分级为 Class II。记录列出批次 6B093FI 与 6F511F1，共 25,220 瓶，分销范围标注为 VA。召回启动日为 2026-09-17，报告日期为 2026-10-07，状态为 Ongoing。
记录列出该滴眼液因无菌保证不足被列为 Class II 召回的批次、瓶数与分销范围，可用于核对召回分级与记录日期含义。
FDA 药品召回执法报告 — D-0874-2026
报告发布日期：2026-10-07。这是执法报告日期，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，不得用于追踪召回生命周期。以下其他日期保留其各自名称所表示的含义。
完整官方产品记录（包括 openFDA 统一标识符）：
{
"address_1": "1 Sivagangai Main Road",
"address_2": "",
"center_classification_date": "20260928",
"city": "Madurai",
"classification": "Class II",
"code_info": "Batch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28",
"country": "India",
"distribution_pattern": "VA",
"event_id": "99903",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"M018"
],
"brand_name": [
"FOCUS PI"
],
"generic_name": [
"HYPROMELLOSE EYE DROPS 0.7%"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"COVALENT MEDICAL"
],
"package_ndc": [
"82724-007-19"
],
"product_ndc": [
"82724-007"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"rxcui": [
"2743251"
],
"spl_id": [
"7d464072-62dd-4b68-8558-9008989000ad"
],
"spl_set_id": [
"e9b2afdd-049a-3987-e053-2a95a90a6cbb"
],
"substance_name": [
"HYPROMELLOSE 2910 (4000 MPA.S)"
],
"unii": [
"RN3152OP35"
]
},
"postal_code": "N/A",
"product_description": "FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19",
"product_quantity": "25,220 bottles",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260917",
"recall_number": "D-0874-2026",
"recalling_firm": "Aurolab Trust",
"report_date": "20261007",
"state": "",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov