Carolina Infusion, Llc: Tirzepatide/cyanocobalamin 76/2 Mg/ml Injectable
Carolina Infusion, LLC is recalling injectable syringes containing tirzepatide and cyanocobalamin that were distributed nationwide because the company cannot guarantee the products are sterile. The recall is due to issues with the bacteriostatic water used in formulation and the processing equipment used to make the compound. The affected product was dispensed in single-use syringes according to individual patient prescriptions.
- Recalling firm
- Carolina Infusion, LLC
- Product
- TIRZEPATIDE/CYANOCOBALAMIN 76/2 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-10
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/bcd4d5fe-af43-44f3-81f7-b7ffbdcb7df0