Class IIDrugOngoing

Carolina Infusion, LLC

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

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-0020-2027
Event ID: 99867
Recall initiated: Sep 10, 2026
Classified: Oct 8, 2026
Reported: Oct 14, 2026
Quantity: 15 mls - in patient specific syringe doses
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: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026.