FDA 执法报告 D-0042-2027 收录 American Health Packaging 甲氧氯普胺片 II 类召回，原因为混入外来片剂或胶囊

FDA 药品召回执法报告 — D-0042-2027

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。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，不得用于追踪召回生命周期。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（包括 openFDA 统一标识符）：

{

"address_1": "2550 John Glenn Ave Ste A",

"address_2": "",

"center_classification_date": "20261014",

"city": "Columbus",

"classification": "Class II",

"code_info": "Lot 1028135, 1029555; Exp. Date 07/31/2027",

"country": "United States",

"distribution_pattern": "US Nationwide",

"event_id": "100100",

"initial_firm_notification": "Letter",

"more_code_info": "",

"openfda": {

"application_number": [

"ANDA072801"

],

"brand_name": [

"METOCLOPRAMIDE"

],

"generic_name": [

"METOCLOPRAMIDE"

],

"manufacturer_name": [

"American Health Packaging"

],

"original_packager_product_ndc": [

"0093-2204",

"0093-2203"

],

"package_ndc": [

"60687-620-11",

"60687-620-01",

"60687-631-11",

"60687-631-01"

],

"product_ndc": [

"60687-620",

"60687-631"

],

"product_type": [

"HUMAN PRESCRIPTION DRUG"

],

"route": [

"ORAL"

],

"rxcui": [

"311666",

"311668"

],

"spl_id": [

"223f574d-b64f-236d-e063-6294a90aada1"

],

"spl_set_id": [

"998f1782-bbfa-469b-9fe1-c612e8588f70"

],

"substance_name": [

"METOCLOPRAMIDE HYDROCHLORIDE"

],

"unii": [

"W1792A2RVD"

]

},

"postal_code": "43217-1188",

"product_description": "Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11",

"product_quantity": "5,363 cartons",

"product_type": "Drugs",

"reason_for_recall": "Presence of Foreign Tablets/Capsules",

"recall_initiation_date": "20261006",

"recall_number": "D-0042-2027",

"recalling_firm": "American Health Packaging",

"report_date": "20261021",

"state": "OH",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}