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 drug enforcement D-0716-2026: Rohto-Mentholatum (Vietnam) Co., Ltd. — Lack of Assurance of Sterility
openFDA 执法报告 D-0716-2026 显示，Rohto-Mentholatum（越南）因无菌保证不足（Lack of Assurance of Sterility）自愿召回在美国全国分销的 Rohto Cooling Eye Drops Max Strength 滴眼液，分类为 Class II。
记录列出本次召回的分级、批次效期范围与美国全国分销情况，可用于核对无菌保证缺陷的召回边界。
FDA drug recall enforcement report — D-0716-2026
Report issued: 2026-07-29. 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": "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"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov