FDA 召回执法报告 D-0040-2027：Houston Rx LLC 替尔泊肽/烟酰胺注射液因无菌保证不足列为 Class II
FDA drug enforcement D-0040-2027: Houston Rx LLC — Lack of assurance of sterility.
FDA 召回执法报告将 Houston Rx LLC 的替尔泊肽/烟酰胺 2mL 注射液（40mg/瓶）召回列为 Class II，原因为无菌保证不足。记录涉及批号 TZN-080326-20/2-2、64 瓶，分销范围为美国全国，由企业自愿发起，状态为持续中。召回启动日为 2026-09-25，执法报告日期为 2026-10-21，报告日期并非召回启动日。
记录列出因无菌保证不足而发起、状态仍在持续的 Class II 召回，可帮助核对批号、数量与分销范围。
FDA 药品召回执法报告 — D-0040-2027
报告发布日期：2026-10-21。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": "15340 Vantage Pkwy E Ste 220",
"address_2": "",
"center_classification_date": "20261013",
"city": "Houston",
"classification": "Class II",
"code_info": "Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.",
"country": "United States",
"distribution_pattern": "Nationwide in the USA.",
"event_id": "99990",
"initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
"more_code_info": "",
"openfda": {},
"postal_code": "77032-1901",
"product_description": "Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.",
"product_quantity": "64 vials",
"product_type": "Drugs",
"reason_for_recall": "Lack of assurance of sterility.",
"recall_initiation_date": "20260925",
"recall_number": "D-0040-2027",
"recalling_firm": "Houston Rx LLC",
"report_date": "20261021",
"state": "TX",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov