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openFDA 已分级药品召回执法报告·· 8 天前精选AI 评分68

FDA 执法报告 D-0037-2027 将 Apothecary Pharma 的 NAD+ 注射液召回列为 II 类

FDA drug enforcement D-0037-2027: Apothecary Pharma LLC — Lack of Assurance of Sterility

AI 导读

FDA 执法报告 D-0037-2027 将 Apothecary Pharma LLC 的 Apothecary NAD+ 注射液 200 mg/mL、6 mL 无菌多剂量瓶召回列为 II 类,原因为缺乏无菌保证。

推荐理由

记录列出该无菌注射剂召回的分类等级、批次、全国分销范围及企业自愿发起状态,便于核对召回档案要素。

正文 · AI 翻译

FDA 药品召回执法报告 — D-0037-2027

报告发布日期:2026-10-14。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。无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": "1913 Evans Rd",

"address_2": "N/A",

"center_classification_date": "20261008",

"city": "Cary",

"classification": "Class II",

"code_info": "Lot #: AP-202647, BUD 13-Oct-2026",

"country": "United States",

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

"event_id": "99952",

"initial_firm_notification": "Letter",

"openfda": {},

"postal_code": "27513-2041",

"product_description": "Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.",

"product_quantity": "1 vial",

"product_type": "Drugs",

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

"recall_initiation_date": "20260924",

"recall_number": "D-0037-2027",

"recalling_firm": "Apothecary Pharma LLC",

"report_date": "20261014",

"state": "NC",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}

来源:openFDA 已分级药品召回执法报告 · api.fda.gov