Carolina Infusion, Llc: Sermorelin Acetate 1 Mg/ml Injectable
Recall Summary Carolina Infusion, LLC is recalling Sermorelin Acetate 1 mg/mL injectable syringes distributed nationwide because the company cannot guarantee the product is sterile. The issue stems from problems with the bacteriostatic water used in the formulation and the processing equipment used to prepare the medication. This is a Class II recall affecting patients who received this compounded injectable medication.
- Recalling firm
- Carolina Infusion, LLC
- Product
- 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
- 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/358b2ebb-0c48-4fa0-9e28-37a089c22723