Class IIDrugOngoing

Carolina Infusion, LLC

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

Reason for recall

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

Details

Recall number: D-0028-2027
Event ID: 99867
Recall initiated: Sep 10, 2026
Classified: Oct 8, 2026
Reported: Oct 14, 2026
Quantity: 29.6 mls - in patient specific syringe dose
Distribution: Nationwide within the U.S
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Ridgeland, SC, United States
Lot / 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.