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 recall enforcement report — D-0854-2026

Report issued: 2026-09-30. 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": "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"

}