{"recall":{"id":"fda-drug-99867","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Carolina Infusion, LLC recalls 16 products","firm":"Carolina Infusion, LLC","date":"2026-09-10","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"TIRZEPATIDE 26 MG/ML INJECTABLE, 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;","code":"Lots: 09012026@3, BUD: 10/16/2026; 08032026@16, BUD: 9/17/2026; 08052026@8, BUD: 9/19/2026; 08072026@13, BUD: 9/21/2026.","quantity":"5.6 mLs - in patient specific syringe doses","number":"D-0017-2027","classification":"Class II"},{"name":"SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936","code":"Lot: 08262026@6, BUD:10/10/2026.","quantity":"8 x 0.1 ml syringes","number":"D-0018-2027","classification":"Class II"},{"name":"SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, 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","code":"Lot: 07282026@3, BUD: 9/11/2026; 08252026@9, BUD: 10/9/2026; 08042026@12, BUD: 9/18/2026; 08072026@15, BUD: 9/21/2026.","quantity":"57.0 mls - in patient specific syringe doses","number":"D-0019-2027","classification":"Class II"},{"name":"SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland","code":"Lot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026.","quantity":"15 mls - in patient specific syringe doses","number":"D-0020-2027","classification":"Class II"},{"name":"QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, 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","code":"LOT: 08032026@24, BUD: 09/17/2026.","quantity":"5 mls in patient specific syringe doses","number":"D-0021-2027","classification":"Class II"},{"name":"Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, 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,","code":"Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026.","quantity":"15 mLs - in patient specific syringe doses","number":"D-0022-2027","classification":"Class II"},{"name":"Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, 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,","code":"Lot: 07242026@7, BUD: 09/7/2026.","quantity":"5 mL in patient specific syringe doses","number":"D-0023-2027","classification":"Class II"},{"name":"Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, 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","code":"Lot:08042026@8, BUD: 9/18/2026.","quantity":"3 ML in patient specific syringe dose","number":"D-0024-2027","classification":"Class II"},{"name":"Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, 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","code":"Lot:08062026@10, BUD: 9/20/2026.","quantity":"5 mL in patient specific syringe dose","number":"D-0025-2027","classification":"Class II"},{"name":"SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, 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","code":"Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .","quantity":"82.9 mls - in patient specific syringe dose","number":"D-0026-2027","classification":"Class II"},{"name":"TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, 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","code":"Lot:07212026@18, BUD: 9/4/2026; 07222026@14, BUD: 9/5/2026; 07292026@8, BUD: 9/12/2026; 08052026@14, BUD: 9/19/2026; 08142026@1, BUD: 9/28/2026; 08192026@10, BUD: 10/3/2026; 08242026@25, BUD: 10/8/2026; 08282026@2, BUD: 10/12/2026; 08292026@1, BUD:10/13/2026;","quantity":"297 mL - in patient specific syringe dose","number":"D-0027-2027","classification":"Class II"},{"name":"TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, 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","code":"Lot:07252026@3, BUD: 9/8/2026; 08112026@5, BUD: 9/25/2026; 08212026@21, BUD: 10/5/2026; 08282026@3, BUD: 10/12/2026.","quantity":"29.6 mls - in patient specific syringe dose","number":"D-0028-2027","classification":"Class II"},{"name":"TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, 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","code":"Lot:08032026@23, BUD: 9/17/2026; 08172026@19, BUD: 10/1/2026; 08262026@13, BUD: 10/10/2026.","quantity":"24.8 mLs -in patient specific syringe dose","number":"D-0029-2027","classification":"Class II"},{"name":"TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, 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;","code":"Lot:07212026@9, BUD: 9/4/2026; 07252026@2, BUD: 9/8/2026; 08122026@14, BUD: 9/26/2026; 08272026@8, BUD: 10/11/2026; 08312026@18, BUD: 10/15/2026.","quantity":"30.4 mLs - in patient specific syringe dose","number":"D-0030-2027","classification":"Class II"},{"name":"Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, 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","code":"Lot: 07212026@1, BUD: 9/10/2026.","quantity":"10 ml -in patient specific syringe dose","number":"D-0031-2027","classification":"Class II"},{"name":"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","code":"Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. .","quantity":"20 mLs - in patient specific syringe dose","number":"D-0032-2027","classification":"Class II"}],"reason":"Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Lack of Assurance of Sterility: Related to processing equipment used in compounded product.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the U.S","nationwide":true,"states":[],"units":"5.6 mLs - in patient specific syringe doses; 8 x 0.1 ml syringes; 57.0 mls - in patient specific syringe doses; 15 mls - in patient specific syringe doses; 5 mls in patient specific syringe doses; 15 mLs - in patient specific syringe doses; 5 mL in patient specific syringe doses; 3 ML in patient specific syringe dose; 5 mL in patient specific syringe dose; 82.9 mls - in patient specific syringe dose; 297 mL - in patient specific syringe dose; 29.6 mls - in patient specific syringe dose; 24.8 mLs -in patient specific syringe dose; 30.4 mLs - in patient specific syringe dose; 10 ml -in patient specific syringe dose; 20 mLs - in patient specific syringe dose","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99867","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e6c4adc04e8ee8c7","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99867","record":[{"status":"Ongoing","city":"Ridgeland","state":"SC","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99867","recalling_firm":"Carolina Infusion, LLC","address_1":"95 Bees Creek Rd","address_2":"N/A","postal_code":"29936-7540","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0017-2027","product_description":"TIRZEPATIDE 26 MG/ML INJECTABLE, 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":"5.6 mLs - in patient specific syringe doses","reason_for_recall":"Lack of Assurance of Sterility: Related to formulation using bacteriostic water; 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