FDA 执法报告 D-0856-2026：Sterling Pharmaceutical Services 因缺乏无菌保证召回 5% 高渗氯化钠滴眼液，分级 Class II
FDA drug enforcement D-0856-2026: Sterling Pharmaceutical Services LLC — Lack of Assurance of Sterility
FDA 在执法报告 D-0856-2026 中将 Sterling Pharmaceutical Services 自愿召回的 5% 高渗氯化钠滴眼液列为 Class II，原因为缺乏无菌保证。
该执法报告列出 Sterling Pharmaceutical Services 召回产品的分级、批次与分销范围，可用于核对无菌保证缺陷的产品层面信息。
FDA drug recall enforcement report — D-0856-2026
Report issued: 2026-09-30. 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": "109 S 2nd St",
"address_2": "",
"center_classification_date": "20260921",
"city": "Dupo",
"classification": "Class II",
"code_info": "Lot #3192, Exp Date 01/312027; 3293, 3336 Exp Date 06/30/2027",
"country": "United States",
"distribution_pattern": "USA Nationwide",
"event_id": "99712",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"M018"
],
"brand_name": [
"SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%"
],
"generic_name": [
"SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Reliable 1 Laboritories LLC"
],
"package_ndc": [
"69618-077-55"
],
"product_ndc": [
"69618-077"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"rxcui": [
"730780"
],
"spl_id": [
"2bc84e6b-f871-1be7-e063-6294a90ac878"
],
"spl_set_id": [
"29175c17-223e-5e92-e063-6294a90a71d2"
],
"substance_name": [
"SODIUM CHLORIDE"
],
"unii": [
"451W47IQ8X"
]
},
"postal_code": "62239-1351",
"product_description": "Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.",
"product_quantity": "11083 bottles",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260820",
"recall_number": "D-0856-2026",
"recalling_firm": "Sterling Pharmaceutical Services LLC",
"report_date": "20260930",
"state": "IL",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov