FDA 执法报告 D-0688-2026：Bell Pharmaceuticals 的 CAREone 过氧化脲 6.5% 因效价不足被列为 Class II 召回
FDA drug enforcement D-0688-2026: Bell Pharmaceuticals, Inc — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA 药品召回执法报告 D-0688-2026 显示，Bell Pharmaceuticals 的 CAREone 过氧化脲 6.5%（NDC 72476-838-34）因低 pH 和效价显著偏低（~0.6%）被列为 Class II 召回。
该执法报告记录了一批过氧化脲产品因效价偏低被列入 Class II 召回的批次与分销范围，可供核对召回分类与产品标识信息。
FDA drug recall enforcement report — D-0688-2026
Report issued: 2026-07-22. 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": "200 W Beaver St",
"address_2": "",
"center_classification_date": "20260714",
"city": "Belle Plaine",
"classification": "Class II",
"code_info": "Lot:1505141, exp 2027-04.",
"country": "United States",
"distribution_pattern": "U.S Nationwide",
"event_id": "99278",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {},
"postal_code": "56011-1894",
"product_description": "CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.",
"product_quantity": "1,201 units",
"product_type": "Drugs",
"reason_for_recall": "SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).",
"recall_initiation_date": "20260625",
"recall_number": "D-0688-2026",
"recalling_firm": "Bell Pharmaceuticals, Inc",
"report_date": "20260722",
"state": "MN",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov