Carolina Infusion, LLC: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific pa
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Carolina Infusion, LLC
- Product
- 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
- Reason / hazard
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the U.S
- Recall initiated
- 2026-09-10
- Code info
- 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;
- Product quantity
- 297 mL - in patient specific syringe dose
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Ridgeland
- State
- SC
- Country
- United States
- Event id
- 99867
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