FDA 执法报告 D-0041-2027：Houston Rx LLC 因缺乏过程控制召回 Sermorelin 注射液

FDA 药品召回执法报告 — D-0041-2027

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# SER-081726-1-10, Beyond Use Date: 10/01/2026.",

"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": "Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.",

"product_quantity": "7 vials",

"product_type": "Drugs",

"reason_for_recall": "Lack of process control",

"recall_initiation_date": "20260925",

"recall_number": "D-0041-2027",

"recalling_firm": "Houston Rx LLC",

"report_date": "20261021",

"state": "TX",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}