← FDA ENFORCEMENT
D-0020-2027Class 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
15 mls - in patient specific syringe doses
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

SERMORELIN ACETATE 1 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

Code / lot info

Lot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026.

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 →