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 · 原文

FDA drug recall enforcement report — D-0018-2027

Report issued: 2026-10-14. This is the enforcement report date, not the recall initiation date.

Scope: one classified drug product recall record; event_id may group multiple products. Unclassified records without recall numbers are outside this stream. This record is not a press release or a new enforcement finding.

The openFDA dataset is updated weekly. Report status is not a live recall status and must not be used to track the recall lifecycle. Other dates below retain their named meanings.

Complete official product record (including openFDA harmonized identifiers):

{

"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"

}