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 drug enforcement D-0042-2027: American Health Packaging — Presence of Foreign Tablets/Capsules
FDA 执法报告 D-0042-2027 收录 American Health Packaging 的甲氧氯普胺片 5 mg 自愿召回，原因为存在外来片剂或胶囊。
记录给出甲氧氯普胺片因混入外来片剂或胶囊而自愿召回的批次、数量与分销范围，便于核对涉及产品。
FDA drug recall enforcement report — D-0042-2027
Report issued: 2026-10-21. 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": "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"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov