FDA 执法报告 D-0032-2027：Carolina Infusion 复合 Tri-MIX 注射器因无菌保证不足列为 II 类召回

FDA drug recall enforcement report — D-0032-2027

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": "95 Bees Creek Rd",

"address_2": "N/A",

"center_classification_date": "20261008",

"city": "Ridgeland",

"classification": "Class II",

"code_info": "Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. .",

"country": "United States",

"distribution_pattern": "Nationwide within the U.S",

"event_id": "99867",

"initial_firm_notification": "E-Mail",

"openfda": {},

"postal_code": "29936-7540",

"product_description": "Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936",

"product_quantity": "20 mLs - in patient specific syringe dose",

"product_type": "Drugs",

"reason_for_recall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",

"recall_initiation_date": "20260910",

"recall_number": "D-0032-2027",

"recalling_firm": "Carolina Infusion, LLC",

"report_date": "20261014",

"state": "SC",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}