FDA 执法报告 D-0716-2026：Rohto-Mentholatum（越南）因无菌保证不足召回滴眼液

FDA 药品召回执法报告 — D-0716-2026

报告发布日期：2026-07-29。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，不得用于跟踪召回生命周期。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": "No. 16 Vsip, Street No. 5",

"address_2": "Vietnam Singapore Industrial Park",

"center_classification_date": "20260723",

"city": "Ho Chi Minh",

"classification": "Class II",

"code_info": "Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08.",

"country": "Vietnam",

"distribution_pattern": "Nationwide within the United States",

"event_id": "99440",

"initial_firm_notification": "Letter",

"openfda": {},

"postal_code": "N/A",

"product_description": "Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1",

"product_quantity": "6076306 cartons",

"product_type": "Drugs",

"reason_for_recall": "Lack of Assurance of Sterility",

"recall_initiation_date": "20260714",

"recall_number": "D-0716-2026",

"recalling_firm": "Rohto-Mentholatum (Vietnam) Co., Ltd.",

"report_date": "20260729",

"state": "N/A",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}