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openFDA 已分级药品召回执法报告·· 7 天前精选AI 评分70

FDA 召回执法报告 D-0878-2026:SV Labs Toronto 过氧化苯甲酰洗剂因微生物污染列为 Class II

FDA drug enforcement D-0878-2026: SV Labs Toronto Corporation — Microbial contamination of topical product.

AI 导读

FDA 召回执法报告记录 SV Labs Toronto Corporation 的过氧化苯甲酰洗剂(USP,5%)因外用产品微生物污染被列为 Class II 召回。

推荐理由

记录列出 Class II 分级、批号、有效期与仅限伊利诺伊州的分销范围,可定位到具体产品与批次。

正文 · AI 翻译

FDA 药品召回执法报告 — D-0878-2026

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": "296 Orenda Rd",

"address_2": "",

"center_classification_date": "20260930",

"city": "Brampton",

"classification": "Class II",

"code_info": "Lot #: 0525-02-345, Exp. Date 02/2027",

"country": "Canada",

"distribution_pattern": "IL only",

"event_id": "99866",

"initial_firm_notification": "E-Mail",

"more_code_info": "",

"openfda": {},

"postal_code": "N/A",

"product_description": "Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63",

"product_quantity": "",

"product_type": "Drugs",

"reason_for_recall": "Microbial contamination of topical product.",

"recall_initiation_date": "20260901",

"recall_number": "D-0878-2026",

"recalling_firm": "SV Labs Toronto Corporation",

"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