FDA 药品执法报告 D-0855-2026：Sterling Pharmaceutical Services 因无菌保证不足召回羧甲基纤维素钠滴眼液
FDA drug enforcement D-0855-2026: Sterling Pharmaceutical Services LLC — Lack of Assurance of Sterility
openFDA 药品召回执法报告 D-0855-2026 显示，Sterling Pharmaceutical Services LLC 自愿召回 AvKare 羧甲基纤维素钠滴眼液 0.5%（15 mL 瓶装），原因为无菌保证不足，分级为 Class II。
该执法记录显示召回分级为 Class II，可帮助读者核对涉及的批号与全美分销范围。
FDA drug recall enforcement report — D-0855-2026
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# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027",
"country": "United States",
"distribution_pattern": "USA Nationwide",
"event_id": "99712",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"M018"
],
"brand_name": [
"CARBOXYMETHYLCELLULOSE SODIUM"
],
"generic_name": [
"CARBOXYMETHYLCELLULOSE SODIUM"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"AvPAK"
],
"package_ndc": [
"50268-068-15",
"50268-068-02"
],
"product_ndc": [
"50268-068"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"rxcui": [
"1188426"
],
"spl_id": [
"435361c6-ed83-3e7b-e063-6394a90ac92f"
],
"spl_set_id": [
"b479d2ae-4b59-916a-e053-2995a90af8ec"
],
"substance_name": [
"CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM"
],
"unii": [
"K679OBS311"
]
},
"postal_code": "62239-1351",
"product_description": "AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15",
"product_quantity": "12,864 packs",
"product_type": "Drugs",
"reason_for_recall": "Lack of Assurance of Sterility",
"recall_initiation_date": "20260820",
"recall_number": "D-0855-2026",
"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