← FDA ENFORCEMENT
D-0026-2027Class II

Carolina Infusion, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Carolina Infusion, LLC
Product type
Drug
Status
Ongoing
Report date
2026-10-14
Distribution
Nationwide within the U.S
Firm state
SC
Product quantity
82.9 mls - in patient specific syringe dose
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

SEMAGLUTIDE/CYANOCOBALAMIN 9/2 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

Code / lot info

Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →