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 drug recall enforcement report — D-0016-2027
Report issued: 2026-10-14. 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": "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) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01",
"product_quantity": "49 vials",
"product_type": "Drugs",
"reason_for_recall": "Presence of particulate matter.",
"recall_initiation_date": "20260923",
"recall_number": "D-0016-2027",
"recalling_firm": "J&J INNOVATIVE MEDICINE",
"report_date": "20261014",
"state": "PA",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov