FDA 执法报告 D-0016-2027：IMAAVY 注射液因存在颗粒物召回 Lot JNYJ1208，列为 Class II
FDA drug enforcement D-0016-2027: J&J INNOVATIVE MEDICINE — Presence of particulate matter.
openFDA 执法报告 D-0016-2027 记录 J&J INNOVATIVE MEDICINE 自主召回 IMAAVY（nipocalimab-aahu）注射液 Lot JNYJ1208，原因为存在颗粒物，FDA 分级为 Class II。
报告给出批号、规格、分销范围与 Class II 分级信息，可用于核对颗粒物缺陷产品的召回边界与记录要素。
FDA 药品召回执法报告 — D-0016-2027
报告发布日期：2026-10-14。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。无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（含 openFDA 统一标识符）：
{
"address_1": "200 Great Valley Pkwy",
"address_2": "N/A",
"center_classification_date": "20261008",
"city": "Malvern",
"classification": "Class II",
"code_info": "Lot JNYJ1208; Exp. 10/30/2027",
"country": "United States",
"distribution_pattern": "OH",
"event_id": "99972",
"initial_firm_notification": "Letter",
"openfda": {
"application_number": [
"BLA761430"
],
"brand_name": [
"IMAAVY"
],
"generic_name": [
"NIPOCALIMAB-AAHU"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Janssen Biotech, Inc."
],
"package_ndc": [
"57894-801-01",
"57894-800-01"
],
"product_ndc": [
"57894-800",
"57894-801"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"INTRAVENOUS"
],
"rxcui": [
"2712699",
"2712706",
"2712708",
"2712709"
],
"spl_id": [
"38376edc-230b-4b2b-8bb6-55b9dccea7a5"
],
"spl_set_id": [
"8886274c-f2b2-48af-85c1-2f90bfe304b8"
],
"substance_name": [
"NIPOCALIMAB"
],
"unii": [
"87M90CV8NC"
]
},
"postal_code": "19355-1307",
"product_description": "IMAAVY (nipocalimab-aahu) 注射液，300 mg /1.62 mL（185 mg/mL）/单剂量瓶，稀释后用于静脉输注，处方药，生产商：Janssen Biotech, Inc., Horsham, PA 19044。NDC: 57894-800-01",
"product_quantity": "49 瓶",
"product_type": "药品",
"reason_for_recall": "存在颗粒物。",
"recall_initiation_date": "20260923",
"recall_number": "D-0016-2027",
"recalling_firm": "J&J INNOVATIVE MEDICINE",
"report_date": "20261014",
"state": "PA",
"status": "进行中",
"voluntary_mandated": "自愿：企业发起"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov