FDA 召回执法报告 D-0875-2026：TerSera 的 Zoladex 3.6 mg 植入剂因运输温度失控被列为 Class II 召回
FDA drug enforcement D-0875-2026: TerSera Therapeutics LLC — Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
FDA 召回执法报告 D-0875-2026 显示，TerSera Therapeutics LLC 自愿召回 Zoladex（戈舍瑞林）3.6 mg 植入剂，原因是产品在非温控的 FedEx 拖车中于室外环境条件下放置 25.5 小时，分类为 Class II。
执法报告记录了一批 Zoladex 植入剂因运输途中温控缺失被列为 Class II 召回，可核对批次与分销范围。
FDA 药品召回执法报告 — D-0875-2026
报告发布日期：2026-10-07。这是执法报告日期，而非召回启动日期。
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，不得用于追踪召回生命周期。下文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": "520 Lake Cook Rd Ste 500",
"address_2": "",
"center_classification_date": "20260928",
"city": "Deerfield",
"classification": "Class II",
"code_info": "Lot#: YN0099, Exp 01/31/2028",
"country": "United States",
"distribution_pattern": "USA Nationwide",
"event_id": "99795",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"NDA019726"
],
"brand_name": [
"ZOLADEX"
],
"generic_name": [
"GOSERELIN"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"TerSera Therapeutics LLC"
],
"package_ndc": [
"70720-950-36"
],
"product_ndc": [
"70720-950"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"SUBCUTANEOUS"
],
"rxcui": [
"105641",
"310592"
],
"spl_id": [
"c48edbf8-425f-4e11-8892-467e868d9fba"
],
"spl_set_id": [
"294b168b-6e5f-4db9-bf70-d599271458b3"
],
"substance_name": [
"GOSERELIN ACETATE"
],
"unii": [
"6YUU2PV0U8"
]
},
"postal_code": "60015-5633",
"product_description": "Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.",
"product_quantity": "296 cartons",
"product_type": "Drugs",
"reason_for_recall": "Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.",
"recall_initiation_date": "20260831",
"recall_number": "D-0875-2026",
"recalling_firm": "TerSera Therapeutics LLC",
"report_date": "20261007",
"state": "IL",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov