FDA 召回执法报告 D-0877-2026：Apotex 帕罗西汀缓释片因溶出度不合格列为 II 类召回
FDA drug enforcement D-0877-2026: Apotex Corp. — Failed dissolution specifications.
FDA 已分类召回执法报告 D-0877-2026 记录 Apotex Corp. 的帕罗西汀缓释片 37.5mg（30 粒瓶装，NDC 60505-1318-3）因溶出度不合格被列为 II 类召回，企业主动发起，状态为持续进行中。
材料为已分类召回记录，列出产品、批次与召回原因，可用于核对召回范围与召回字段口径。
FDA drug recall enforcement report — D-0877-2026
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": "2400 N Commerce Pkwy Ste 400",
"address_2": "",
"center_classification_date": "20260929",
"city": "Weston",
"classification": "Class II",
"code_info": "Lot# TY9495, Exp Date: 05/2027.",
"country": "United States",
"distribution_pattern": "US Nationwide.",
"event_id": "99978",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"NDA020936"
],
"brand_name": [
"PAROXETINE HYDROCHLORIDE"
],
"generic_name": [
"PAROXETINE HYDROCHLORIDE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Apotex Corp"
],
"package_ndc": [
"60505-1316-3",
"60505-1317-3",
"60505-1318-3",
"60505-3673-3",
"60505-3674-3",
"60505-3675-3"
],
"product_ndc": [
"60505-1316",
"60505-1317",
"60505-1318",
"60505-3673",
"60505-3674",
"60505-3675"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"rxcui": [
"1738803",
"1738805",
"1738807"
],
"spl_id": [
"f66c4702-5904-afb1-5a22-a236e8fa7f25"
],
"spl_set_id": [
"087ff0d3-1761-47ea-a8c1-7c4cb679af97"
],
"substance_name": [
"PAROXETINE HYDROCHLORIDE"
],
"unii": [
"X2ELS050D8"
],
"upc": [
"0360505367436",
"0360505367535",
"0360505367337"
]
},
"postal_code": "33326-3253",
"product_description": "Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3",
"product_quantity": "",
"product_type": "Drugs",
"reason_for_recall": "Failed dissolution specifications.",
"recall_initiation_date": "20260923",
"recall_number": "D-0877-2026",
"recalling_firm": "Apotex Corp.",
"report_date": "20261007",
"state": "FL",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov