TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Status
- Ongoing
- City
- Ridgeland
- State
- SC
- Country
- United States
- Classification
- Class II
- 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
- Distribution pattern
- Nationwide within the U.S
- Recall number
- D-0028-2027
- Product quantity
- 29.6 mls - in patient specific syringe dose
- 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
- Center classification date
- 20261008
- Report date
- 20261014
- Code info
- 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.
- Product description
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