FDA 执法报告 D-0031-2027：Carolina Infusion 复方注射剂因无菌保证不足被列为 II 类召回

FDA 药品召回执法报告 — D-0031-2027

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。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: 07212026@1, BUD: 9/10/2026.",

"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": "Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936",

"product_quantity": "10 ml -in patient specific syringe dose",

"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-0031-2027",

"recalling_firm": "Carolina Infusion, LLC",

"report_date": "20261014",

"state": "SC",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}