FDA 执法报告 D-0014-2027：Cipla USA 磷霉素氨丁三醇颗粒因杂质或降解指标不合格召回
FDA drug enforcement D-0014-2027: Cipla USA, Inc. — Failed Impurities/Degradation Specifications
FDA 执法报告 D-0014-2027 显示，Cipla USA 因杂质或降解指标不合格，对批号 5KA0405 的磷霉素氨丁三醇口服溶液用颗粒发起 II 类自愿召回。
记录列明召回产品的批号、有效期与分销范围为美国全国，可用于核对本次召回的分类与状态口径。
FDA drug recall enforcement report — D-0014-2027
Report issued: 2026-10-14. 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": "10 Independence Blvd",
"address_2": "N/A",
"center_classification_date": "20261006",
"city": "Warren",
"classification": "Class II",
"code_info": "Lot#: 5KA0405, Exp 12/31/2026.",
"country": "United States",
"distribution_pattern": "USA Nationwide.",
"event_id": "99930",
"initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
"openfda": {
"application_number": [
"ANDA211881"
],
"brand_name": [
"FOSFOMYCIN TROMETHAMINE"
],
"generic_name": [
"FOSFOMYCIN TROMETHAMINE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Cipla USA Inc."
],
"package_ndc": [
"69097-579-67"
],
"product_ndc": [
"69097-579"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"rxcui": [
"808917"
],
"spl_id": [
"80c866f4-c984-469e-b2a5-5c23f29b9750"
],
"spl_set_id": [
"d101b5d8-bffc-4ee6-b93b-4589fcb8750d"
],
"substance_name": [
"FOSFOMYCIN TROMETHAMINE"
],
"unii": [
"7FXW6U30GY"
]
},
"postal_code": "07059-2730",
"product_description": "Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.",
"product_quantity": "N/A",
"product_type": "Drugs",
"reason_for_recall": "Failed Impurities/Degradation Specifications",
"recall_initiation_date": "20260918",
"recall_number": "D-0014-2027",
"recalling_firm": "Cipla USA, Inc.",
"report_date": "20261014",
"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