FDA 执法报告 D-0010-2027 将 Ajanta Pharma USA 雷诺嗪缓释片召回列为 II 级
FDA drug enforcement D-0010-2027: Ajanta Pharma USA Inc — Failed Dissolution Specifications: below specification
FDA 将 Ajanta Pharma USA 的雷诺嗪缓释片 1000 mg 召回列为 II 级，原因为溶出度不合格（低于标准）。该召回由企业自愿发起，编号 D-0010-2027，涉及批次 DJ25134，效期 2028 年 11 月 30 日，在全美分销，记录状态为 Ongoing。
记录列出溶出度不合格的分类、批次与分销范围，可用于核对召回编号与状态字段的含义。
FDA drug recall enforcement report — D-0010-2027
Report issued: 2026-10-07. 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": "400 Crossing Blvd Ste 102",
"address_2": "",
"center_classification_date": "20261006",
"city": "Bridgewater",
"classification": "Class II",
"code_info": "Lot: DJ25134, Exp 11/30/2028",
"country": "United States",
"distribution_pattern": "Nationwide in the US.",
"event_id": "99893",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"ANDA210054"
],
"brand_name": [
"RANOLAZINE"
],
"generic_name": [
"RANOLAZINE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Ajanta Pharma USA Inc."
],
"nui": [
"N0000175427",
"N0000190114",
"N0000185503",
"N0000182137",
"N0000187061"
],
"package_ndc": [
"27241-125-02",
"27241-125-05",
"27241-126-02",
"27241-126-05"
],
"pharm_class_epc": [
"Anti-anginal [EPC]"
],
"pharm_class_moa": [
"Cytochrome P450 3A Inhibitors [MoA]",
"P-Glycoprotein Inhibitors [MoA]",
"Cytochrome P450 2D6 Inhibitors [MoA]",
"Organic Cation Transporter 2 Inhibitors [MoA]"
],
"product_ndc": [
"27241-125",
"27241-126"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"rxcui": [
"616749",
"728231"
],
"spl_id": [
"933f695e-e4f4-4c75-80fc-aea9a30aa13d"
],
"spl_set_id": [
"8bfd1a61-547a-4847-ae4e-480b17da6272"
],
"substance_name": [
"RANOLAZINE"
],
"unii": [
"A6IEZ5M406"
],
"upc": [
"0327241125027",
"0327241126024"
]
},
"postal_code": "08807-2863",
"product_description": "Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02",
"product_quantity": "",
"product_type": "Drugs",
"reason_for_recall": "Failed Dissolution Specifications: below specification",
"recall_initiation_date": "20260917",
"recall_number": "D-0010-2027",
"recalling_firm": "Ajanta Pharma USA Inc",
"report_date": "20261007",
"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