FDA 执法报告 D-0854-2026：SHANTOU Qiwei industrial Co., Ltd 防晒粉饼因 cGMP 偏差列为 Class II 召回
FDA drug enforcement D-0854-2026: SHANTOU Qiwei industrial Co., Ltd — cGMP Deviations
FDA 药品召回执法报告 D-0854-2026 将 SHANTOU Qiwei industrial Co., Ltd 的 MENOW 防晒粉饼（SPF35 PA+++，9g）列为 Class II 召回，原因为 cGMP 偏差。
该执法报告记录一次企业自愿发起的 Class II 召回，可核对批号、数量与仅限加州的销售范围。
FDA 药品召回执法报告 — D-0854-2026
报告发布日期：2026-09-30。这是执法报告日期，而非召回启动日期。
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。报告状态并非实时召回状态，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对应的含义。
完整官方产品记录（包括 openFDA 统一标识符）：
{
"address_1": "Xiashan",
"address_2": "Qiwei Building,Yingbinguan; Chaonan District",
"center_classification_date": "20260918",
"city": "Shantou",
"classification": "Class II",
"code_info": "Lot #: 2024/10/11, Exp. Date 10/10/2027",
"country": "China",
"distribution_pattern": "CA only",
"event_id": "99625",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {},
"postal_code": "N/A",
"product_description": "MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China",
"product_quantity": "2970 units",
"product_type": "Drugs",
"reason_for_recall": "cGMP Deviations",
"recall_initiation_date": "20260808",
"recall_number": "D-0854-2026",
"recalling_firm": "SHANTOU Qiwei industrial Co., Ltd",
"report_date": "20260930",
"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