FDA 执法报告 D-0018-2027：Carolina Infusion 配制司美格鲁肽注射剂因缺乏无菌保证被列为 Class II 召回

FDA drug enforcement D-0018-2027: Carolina Infusion, LLC — Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

AI 导读

FDA 药品召回执法报告 D-0018-2027 显示，Carolina Infusion, LLC 的司美格鲁肽 3 mg/mL 注射剂（8 x 0.1 mL 注射器）因缺乏无菌保证被定为 Class II 召回，召回由企业自主发起，发起日期为 2026 年 9 月 10 日，报告日期为 2026 年 10 月 14 日。

推荐理由

记录列明批次 08262026@6 的配制司美格鲁肽注射剂因无菌保证不足被定为 Class II 召回并在美国全国分发，可供核对召回档案要点。

正文 · AI 翻译

FDA 药品召回执法报告 — D-0018-2027

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对应的含义。

完整官方产品记录（包括 openFDA 统一标识符）：

{

"address_1": "95 Bees Creek Rd",

"address_2": "N/A",

"center_classification_date": "20261008",

"city": "Ridgeland",

"classification": "Class II",

"code_info": "Lot: 08262026@6, BUD:10/10/2026.",

"country": "United States",

"distribution_pattern": "Nationwide within the U.S",

"event_id": "99867",

"initial_firm_notification": "E-Mail",

"openfda": {},

"postal_code": "29936-7540",

"product_description": "SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936",

"product_quantity": "8 x 0.1 ml syringes",

"product_type": "Drugs",

"reason_for_recall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",

"recall_initiation_date": "20260910",

"recall_number": "D-0018-2027",

"recalling_firm": "Carolina Infusion, LLC",

"report_date": "20261014",

"state": "SC",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}