Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance
Carolina Infusion is recalling Sermorelin Acetate injectable (1 MG/ML, 9 ML syringes) distributed nationwide due to lack of assurance of sterility. The manufacturer could not adequately document that the product meets required sterility standards.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a high-risk product (injectable medication) with a confirmed manufacturing issue (lack of sterility assurance), but no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High.
Plain-English summary
Carolina Infusion is recalling Sermorelin Acetate 1 MG/ML Injectable supplied in 9 ML syringes due to lack of assurance of sterility. The affected lots are 08012022@14 (BUD 08/31/2022) and 08192022@7 (BUD 09/23/2022).
Injectable medications must meet strict sterility standards to be safe for use. This product does not have adequate documentation demonstrating that it meets those standards. The manufacturer could not provide sufficient assurance of the product's sterility.
The recalled product was distributed nationwide in the United States. Patients or healthcare facilities with this product should contact their pharmacist or healthcare provider. Consumers should not use the remaining product without consulting a healthcare professional.
The recalled product
- Product
- Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 08012022@14 BUD: 08/31/2022
- 08192022@7 BUD: 09/23/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Carolina Infusion under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
Same manufacturer · Carolina Infusion
See all →- HighInjectable drug product recalled for lack of sterility assurance
FDA (Drugs) · 2022-09-21
- HighInjectable Steroid Product Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- HighInjectable testosterone product recalled for sterility assurance defect
FDA (Drugs) · 2022-09-21
- HighInjectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- HighTRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance
FDA (Drugs) · 2022-09-21
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22