FDA 执法报告 D-0030-2027 收录 Carolina Infusion 替尔泊肽/氰钴胺注射剂无菌保证不足 II 类召回
FDA drug enforcement D-0030-2027: Carolina Infusion, LLC — Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
FDA 执法报告 D-0030-2027 收录 Carolina Infusion 的替尔泊肽/氰钴胺 85/2 mg/mL 单次使用注射器复方产品，原因是无菌保证不足，被列为 II 类召回。
记录列出了该复方注射剂被列为 II 类召回的原因、五个批号及其有效期，便于核对批次范围。
FDA 药品召回执行报告 — D-0030-2027
报告发布日期：2026-10-14。这是执行报告日期，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@9, BUD: 9/4/2026; 07252026@2, BUD: 9/8/2026; 08122026@14, BUD: 9/26/2026; 08272026@8, BUD: 10/11/2026; 08312026@18, BUD: 10/15/2026.",
"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": "TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML 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": "30.4 mLs - 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-0030-2027",
"recalling_firm": "Carolina Infusion, LLC",
"report_date": "20261014",
"state": "SC",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov