FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion Sermorelin Acetate injectable recalled for sterility concerns
What this means
Carolina Infusion LLC is recalling Sermorelin Acetate 1 mg/mL injectable due to concerns that the product may not be sterile. The issue relates to the formulation process and equipment used to prepare the medication.
- Check if you have received Sermorelin Acetate from Carolina Infusion with lot numbers 07292026@12 (expires 09/12/2026) or 07302026@7 (expires 09/13/2026)
- Contact your healthcare provider or pharmacy immediately if you have this product
- Do not use the product unless your doctor instructs you to do so
The agency's original wording
Hazard
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
15 mls - in patient specific syringe doses
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2027More Carolina Infusion recalls
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide injectable recalled for sterility assurance concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide/cyanocobalamin injectable recalled for sterility concerns
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