FDA 执法报告 D-0038-2027：Teva 甲氧氯普胺片因存在外源片剂/胶囊被列为 II 类召回
FDA drug enforcement D-0038-2027: Teva Pharmaceuticals USA, Inc — Presence of Foreign Tablets/Capsules
FDA 执法报告 D-0038-2027 将 Teva Pharmaceuticals USA 的甲氧氯普胺片 5 mg 列为 II 类召回，原因为存在外源片剂/胶囊。
该执法报告记录列出甲氧氯普胺片的召回等级、受影响批号与全美分销范围，便于核对本次召回的覆盖边界。
FDA 药品召回执法报告 — D-0038-2027
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，不得用于追踪召回生命周期。以下其他日期保留其各自名称所表示的含义。
完整官方产品记录（包括 openFDA 统一标识符）：
{
"address_1": "400 Interpace Pkwy Bldg A",
"address_2": "",
"center_classification_date": "20261013",
"city": "Parsippany",
"classification": "Class II",
"code_info": "批号、有效期：[100 片] 批号 8634085、8635085、8636085，有效期 07/2027；[500 片] 批号 8633085，有效期 07/2027",
"country": "United States",
"distribution_pattern": "美国全国。",
"event_id": "100013",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"ANDA070184"
],
"brand_name": [
"METOCLOPRAMIDE"
],
"generic_name": [
"METOCLOPRAMIDE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Teva Pharmaceuticals USA, Inc."
],
"package_ndc": [
"0093-2204-01",
"0093-2204-05",
"0093-2203-01",
"0093-2203-05",
"0093-2203-10"
],
"product_ndc": [
"0093-2203",
"0093-2204"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"rxcui": [
"311666",
"311668"
],
"spl_id": [
"61b5d2d5-1e7b-44ff-a831-1a0de78edecd"
],
"spl_set_id": [
"e15905e0-e0f6-4c8b-ac19-59724d6c4bf0"
],
"substance_name": [
"METOCLOPRAMIDE HYDROCHLORIDE"
],
"unii": [
"W1792A2RVD"
],
"upc": [
"0300932203013",
"0300932204010"
]
},
"postal_code": "07054-1120",
"product_description": "甲氧氯普胺片，USP，5 mg，[100 或 500] 片/瓶，处方药，生产商：Teva Pharmaceuticals，Parsippany, NJ 07054。NDC 100 片：0093-2204-01；NDC 500 片：0093-2204-05",
"product_quantity": "240,448 箱",
"product_type": "药品",
"reason_for_recall": "存在外来片剂/胶囊",
"recall_initiation_date": "20260929",
"recall_number": "D-0038-2027",
"recalling_firm": "Teva Pharmaceuticals USA, Inc",
"report_date": "20261021",
"state": "NJ",
"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