FDA 执法报告将 Carolina Infusion 复方替尔泊肽/氰钴胺注射液召回定为二级（D-0027-2027）
FDA drug enforcement D-0027-2027: Carolina Infusion, LLC — Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
FDA 执法报告收录 Carolina Infusion 复方替尔泊肽/氰钴胺注射液的主动召回（D-0027-2027），定为二级，原因为无菌保证不足。记录将原因指向使用抑菌水配制及复方产品所用加工设备，涉及 9 个批号，有效期至 2026 年 9 月 4 日至 10 月 13 日，在美国全国分销。
该执法报告列出涉事批号、有效期、全国分销范围与二级分类，便于核对本次召回的批次边界。
FDA drug recall enforcement report — D-0027-2027
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:07212026@18, BUD: 9/4/2026; 07222026@14, BUD: 9/5/2026; 07292026@8, BUD: 9/12/2026; 08052026@14, BUD: 9/19/2026; 08142026@1, BUD: 9/28/2026; 08192026@10, BUD: 10/3/2026; 08242026@25, BUD: 10/8/2026; 08282026@2, BUD: 10/12/2026; 08292026@1, BUD:10/13/2026;",
"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 26/2 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": "297 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-0027-2027",
"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