Carolina Infusion recalls Quad-Mix, Tri-Mix and tirzepatide/cyanocobalamin injectables over lack of sterility assurance
The notice says there is a lack of assurance of sterility for these compounded injectable products because of the processing equipment used to make them.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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; TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina…
- Company
- Carolina Infusion, LLC
- Hazard
- Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Units
- 5 mls in patient specific syringe doses; 297 mL - in patient specific syringe dose; 15 mLs - in patient specific syringe doses
- Where sold
- Nationwide within the U.S
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 8, 2026
- Recall started
- September 10, 2026
- FDA enforcement report
- October 14, 2026
- Identifiers
- Codes: LOT: 08032026@24, BUD: 09/17/2026.
- FDA recall number: D-0021-2027
- Codes: 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;
- FDA recall number: D-0027-2027
- Codes: Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026.
- FDA recall number: D-0022-2027
- Codes: Lot: 07242026@7, BUD: 09/7/2026.
- FDA recall number: D-0023-2027
- Codes: Lot:08062026@10, BUD: 9/20/2026.
- FDA recall number: D-0025-2027
- Codes: Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. .
- FDA recall number: D-0032-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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 | 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 | 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, | 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,
- Reason for recall
- Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide within the U.S
- Quantity
- 5 mls in patient specific syringe doses; 297 mL - in patient specific syringe dose; 15 mLs - in patient specific syringe doses; 5 mL in patient specific syringe doses; 5 mL in patient specific syringe dose; 20 mLs - in patient specific syringe dose
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