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 drug recall enforcement report — D-0875-2026
Report issued: 2026-10-07. 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": "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