FDA 召回执法报告 D-0876-2026：Par Health USA 丁丙诺啡盐酸盐注射液因结晶列为 II 类召回
FDA drug enforcement D-0876-2026: Par Health USA, LLC — Crystallization
FDA 药品召回执法报告 D-0876-2026 显示，Par Health USA, LLC 因结晶原因自愿召回丁丙诺啡盐酸盐注射液 0.3 mg/mL 单剂量瓶，分类为 II 类。
记录列出该注射剂因结晶被列为 II 类召回的批号、效期与全美分销范围，可供核对受影响产品。
FDA drug recall enforcement report — D-0876-2026
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": "870 Parkdale Rd",
"address_2": "",
"center_classification_date": "20260929",
"city": "Rochester",
"classification": "Class II",
"code_info": "Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027",
"country": "United States",
"distribution_pattern": "U.S. Nationwide",
"event_id": "99902",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"ANDA206586"
],
"brand_name": [
"BUPRENORPHINE HYDROCHLORIDE"
],
"generic_name": [
"BUPRENORPHINE HYDROCHLORIDE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Par Health USA, LLC"
],
"package_ndc": [
"42023-179-05"
],
"product_ndc": [
"42023-179"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"INTRAMUSCULAR",
"INTRAVENOUS"
],
"rxcui": [
"238129"
],
"spl_id": [
"32a7af7e-3f90-4881-9075-473644237017"
],
"spl_set_id": [
"34767dda-ce52-4f98-a45f-bb5cee0cd5e6"
],
"substance_name": [
"BUPRENORPHINE HYDROCHLORIDE"
],
"unii": [
"56W8MW3EN1"
]
},
"postal_code": "48307-1740",
"product_description": "Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05",
"product_quantity": "154210 bottles",
"product_type": "Drugs",
"reason_for_recall": "Crystallization",
"recall_initiation_date": "20260908",
"recall_number": "D-0876-2026",
"recalling_firm": "Par Health USA, LLC",
"report_date": "20261007",
"state": "MI",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov