Class II Recall

Carolina Infusion, LLC

Product
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;
Reason
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Classification
Class II
Status
Ongoing
Lot
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.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.