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
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。
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。
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