FDA 执法报告 D-0712-2026：Ascend Laboratories 的氨氯地平与奥美沙坦酯片因溶出度不合格及奥美沙坦酯含量低于标准被列为 Class II 召回
FDA drug enforcement D-0712-2026: Ascend Laboratories, LLC — Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
FDA 于 2026 年 7 月 29 日发布的药品召回执法报告 D-0712-2026 收录了 Ascend Laboratories, LLC 对氨氯地平与奥美沙坦酯片（10 mg/20 mg）的 Class II 自愿召回，涉及批号 25121311（有效期 2028 年 3 月 31 日），共 6,192 瓶，在全美分销。
记录列出该批氨氯地平与奥美沙坦酯片的召回分级、批号和全美分销范围，可用于核对执法报告条目。
FDA 药品召回执法报告 — D-0712-2026
报告发布：2026-07-29。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含义。
完整官方产品记录（包括 openFDA 统一标识符）：
{
"address_1": "135 Us Highway 202 206 Ste 15",
"address_2": "N/A",
"center_classification_date": "20260720",
"city": "Bedminster",
"classification": "Class II",
"code_info": "Lot 25121311, expiry 3/31/2028",
"country": "United States",
"distribution_pattern": "Nationwide in the USA",
"event_id": "99385",
"initial_firm_notification": "Letter",
"openfda": {
"application_number": [
"ANDA209042"
],
"brand_name": [
"AMLODIPINE AND OLMESARTAN MEDOXOMIL"
],
"generic_name": [
"AMLODIPINE AND OLMESARTAN MEDOXOMIL"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Ascend Laboratories, LLC"
],
"package_ndc": [
"67877-499-30",
"67877-499-90",
"67877-500-30",
"67877-500-90",
"67877-501-30",
"67877-501-90",
"67877-502-30",
"67877-502-90"
],
"product_ndc": [
"67877-499",
"67877-500",
"67877-501",
"67877-502"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"rxcui": [
"730861",
"730866",
"730869",
"730872"
],
"spl_id": [
"32238052-6c4c-4b29-a59e-524c819c69f1"
],
"spl_set_id": [
"c1204fbe-d086-43cf-bbaa-efec9cd0487c"
],
"substance_name": [
"AMLODIPINE BESYLATE",
"OLMESARTAN MEDOXOMIL"
],
"unii": [
"864V2Q084H",
"6M97XTV3HD"
]
},
"postal_code": "07921-2608",
"product_description": "Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30",
"product_quantity": "6,192 bottles",
"product_type": "Drugs",
"reason_for_recall": "Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications",
"recall_initiation_date": "20260708",
"recall_number": "D-0712-2026",
"recalling_firm": "Ascend Laboratories, LLC",
"report_date": "20260729",
"state": "NJ",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov