Medications & Supplements/Prescription Drugs

Carolina Infusion Injectable Medications Recalled for Lack of Sterility

Agency Publication Date: September 15, 2022

Summary

Carolina Infusion is voluntarily recalling approximately 446 units of various injectable medications, including Testosterone, Semaglutide, and Sermorelin Acetate, because they may not be sterile. The lack of sterility assurance means the products could potentially contain bacteria or other harmful contaminants. No incidents or injuries have been reported to date. These products were distributed nationwide in the United States and were manufactured in South Carolina.

Risk

Using an injectable drug that is not sterile can lead to serious infections at the injection site or throughout the body. These infections could cause severe illness or other medical complications.

What You Should Do

This recall involves various injectable medications in vials and syringes, including L-Carnitine, Sermorelin, Semaglutide, and various Testosterone combinations, manufactured by Carolina Infusion.
Check your medication packaging for specific product names, lot numbers, and 'Beyond Use Dates' (BUD). Because this recall involves dozens of different batches across 20 product categories, see the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist for guidance.
Return any unused product to the place of purchase for a refund, throw it away, or contact Carolina Infusion directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: L-Carnitine 500 mg/mL Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

06132022@17 (Exp 02/15/2023)

Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Product: MIC/B12 25/50/50/1 MG/ML Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

08012022@4 (Exp 01/28/2023)

08082022@12 (Exp 02/04/2023)

Product: MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

05042022@4 (Exp 10/31/2022)

062920222@9 (Exp 12/26/2022)

07262022@3 (Exp 01/22/2023)

Product: Sermorelin Acetate 1 MG/ML Injectable (9 ML)

Variants: 9 ML syringes

Lot Numbers:

08012022@14 (Exp 08/31/2022)

08192022@7 (Exp 09/23/2022)

Product: Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable (0.2 ML)

Variants: 0.2 ML syringe, Rx only

Lot Numbers:

08122022@8 (Exp 09/11/2022)

08162022@3 (Exp 09/15/2022)

Product: Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable (0.4 ML)

Variants: 0.4 ML syringe, Rx only

Lot Numbers:

08152022@14 (Exp 09/14/2022)

Product: Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable (0.4 ML)

Variants: 0.4 ML syringe, Rx only

Lot Numbers:

08172022@1 (Exp 09/16/2022)

Product: TEST CYP (Grapeseed) 200 MG/ML Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

06132022@5 (Exp 09/11/2022)

08082022@17 (Exp 11/06/2022)

Product: TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection

Variants: 3 ML vial, 6 ML vial, Rx only

Lot Numbers:

07182022@9 (Exp 10/16/2022)

07272022@15 (Exp 10/25/2022)

Product: TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable (10 ML)

Variants: 10 ML vial

Lot Numbers (91):

06012022@1 (Exp 08/30/2022)

06012022@2 (Exp 08/30/2022)

06032022@1 (Exp 09/01/2022)

06032022@2 (Exp 09/01/2022)

06032022@13 (Exp 09/01/2022)

06062022@7 (Exp 09/04/2022)

06072022@3 (Exp 09/05/2022)

06072022@4 (Exp 09/05/2022)

06082022@1 (Exp 09/06/2022)

06082022@2 (Exp 09/06/2022)

06082022@4 (Exp 09/06/2022)

06102022@8 (Exp 09/08/2022)

06132022@1 (Exp 09/11/2022)

06132022@7 (Exp 09/11/2022)

06132022@14 (Exp 09/11/2022)

06132022@15 (Exp 09/11/2022)

06142022@7 (Exp 09/12/2022)

06142022@8 (Exp 09/12/2022)

06142022@15 (Exp 09/12/2022)

06152022@2 (Exp 09/13/2022)

06172022@4 (Exp 09/15/2022)

06202022@9 (Exp 09/18/2022)

06202022@10 (Exp 09/18/2022)

06202022@23 (Exp 09/18/2022)

06212022@2 (Exp 09/19/2022)

06222022@2 (Exp 09/20/2022)

06222022@3 (Exp 09/20/2022)

06242022@4 (Exp 09/22/2022)

06242022@5 (Exp 09/22/2022)

06272022@3 (Exp 09/25/2022)

06292022@5 (Exp 09/27/2022)

06292022@6 (Exp 09/27/2022)

07012022@11 (Exp 09/29/2022)

07012022@12 (Exp 09/29/2022)

07052022@3 (Exp 10/03/2022)

07052022@4 (Exp 10/03/2022)

07062022@4 (Exp 10/04/2022)

07062022@5 (Exp 10/04/2022)

07062022@10 (Exp 10/04/2022)

07082022@4 (Exp 10/06/2022)

07082022@5 (Exp 10/06/2022)

07092022@12 (Exp 10/07/2022)

07092022@13 (Exp 10/07/2022)

07112022@16 (Exp 10/09/2022)

07112022@17 (Exp 10/09/2022)

07122022@14 (Exp 10/10/2022)

07122022@15 (Exp 10/10/2022)

07132022@5 (Exp 10/11/2022)

07152022@11 (Exp 10/13/2022)

07152022@12 (Exp 10/13/2022)

Product: TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable (12.6 ML)

Variants: 12.6 ML vial, Rx only

Lot Numbers:

07052022@1 (Exp 10/08/2022)

Product: TRI-MIX 30/1/10 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

06282022@1 (Exp 08/27/2022)

06292022@8 (Exp 08/28/2022)

07012022@19 (Exp 08/30/2022)

07012022@3 (Exp 08/30/2022)

07122022@8 (Exp 09/10/2022)

07132022@9 (Exp 09/11/2022)

07192022@1 (Exp 09/17/2022)

07292022@9 (Exp 09/27/2022)

08032022@10 (Exp 10/02/2022)

08092022@2 (Exp 10/08/2022)

08102022@1 (Exp 10/09/2022)

08102022@6 (Exp 10/09/2022)

08102022@7 (Exp 10/09/2022)

08152022@5 (Exp 10/14/2022)

08192022@1 (Exp 10/18/2022)

08192022@10 (Exp 10/18/2022)

Product: TRI-MIX 30/1/20 Injectable (5 ML)

Variants: 5 ML vial, Rx only

Lot Numbers:

06272022@6 (Exp 08/26/2022)

07212022@3 (Exp 09/19/2022)

07292022@11 (Exp 09/27/2022)

08052022@7 (Exp 10/04/2022)

08102022@5 (Exp 10/09/2022)

08122022@14 (Exp 10/11/2022)

08172022@7 (Exp 10/16/2022)

Product: TRI-MIX 30/1/40 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

07052022@8 (Exp 09/03/2022)

07292022@10 (Exp 09/27/2022)

Product: TRI-MIX 30/1/60 Injectable (5 ML)

Variants: 5 ML vial, Rx only

Lot Numbers:

07012022@6 (Exp 09/20/2022)

07192022@16 (Exp 09/17/2022)

07012022@4 (Exp 08/30/2022)

Product: TRI-MIX 30/2/20 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

07052022@10 (Exp 09/03/2022)

07052022@16 (Exp 09/03/2022)

07122022@11 (Exp 09/08/2022)

07182022@17 (Exp 09/16/2022)

07202022@6 (Exp 09/18/2022)

07252022@9 (Exp 09/23/2022)

0729202222@2 (Exp 09/27/2022)

07292022@13 (Exp 09/27/2022)

08122022@9 (Exp 10/11/2022)

08162022@2 (Exp 10/15/2022)

082620222@1 (Exp 10/25/2022)

Product: TRI-MIX 30/2/40 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

07152022@4 (Exp 09/13/2022)

08152022@15 (Exp 10/14/2022)

Product: TRI-MIX 50/2.5/25 Injectable (2 ML)

Variants: 2 ML vial, Rx only

Lot Numbers:

07052022@2 (Exp 09/03/2022)

Product: QUAD-MIX 30/2/60/0.15 Injectable (5 ML)

Variants: 5 ML vial, Rx only

Lot Numbers:

08022022@12 (Exp 10/01/2022)

Product: QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

08082022@3 (Exp 10/07/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90798

Status: Resolved

Manufacturer: Carolina Infusion

Sold By: Carolina Infusion LLC

Manufactured In: United States

Units Affected: 20 products (1 vial; 3 vials; 4 vials; 8 syringes; 24 syringes; 4 syringes; 4 syringes; 2 vials; 3 vials; 348 vials; 1 vial; 16 vials; 7 vials; 2 vials; 3 vials; 11 vials; 2 vials; 1 vial; 1 vial; 1 vial)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves various injectable medications in vials and syringes, including L-Carnitine, Sermorelin, Semaglutide, and various Testosterone combinations, manufactured by Carolina Infusion.

Check your medication packaging for specific product names, lot numbers, and 'Beyond Use Dates' (BUD). Because this recall involves dozens of different batches across 20 product categories, see the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist for guidance.

Return any unused product to the place of purchase for a refund, throw it away, or contact Carolina Infusion directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: L-Carnitine 500 mg/mL Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

06132022@17 (Exp 02/15/2023)

Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Product: MIC/B12 25/50/50/1 MG/ML Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

08012022@4 (Exp 01/28/2023)

08082022@12 (Exp 02/04/2023)

Product: MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

05042022@4 (Exp 10/31/2022)

062920222@9 (Exp 12/26/2022)

07262022@3 (Exp 01/22/2023)

Product: Sermorelin Acetate 1 MG/ML Injectable (9 ML)

Variants: 9 ML syringes

Lot Numbers:

08012022@14 (Exp 08/31/2022)

08192022@7 (Exp 09/23/2022)

Product: Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable (0.2 ML)

Variants: 0.2 ML syringe, Rx only

Lot Numbers:

08122022@8 (Exp 09/11/2022)

08162022@3 (Exp 09/15/2022)

Product: Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable (0.4 ML)

Variants: 0.4 ML syringe, Rx only

Lot Numbers:

08152022@14 (Exp 09/14/2022)

Product: Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable (0.4 ML)

Variants: 0.4 ML syringe, Rx only

Lot Numbers:

08172022@1 (Exp 09/16/2022)

Product: TEST CYP (Grapeseed) 200 MG/ML Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

06132022@5 (Exp 09/11/2022)

08082022@17 (Exp 11/06/2022)

Product: TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection

Variants: 3 ML vial, 6 ML vial, Rx only

Lot Numbers:

07182022@9 (Exp 10/16/2022)

07272022@15 (Exp 10/25/2022)

Product: TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable (10 ML)

Variants: 10 ML vial

Lot Numbers (91):

06012022@1 (Exp 08/30/2022)

06012022@2 (Exp 08/30/2022)

06032022@1 (Exp 09/01/2022)

06032022@2 (Exp 09/01/2022)

06032022@13 (Exp 09/01/2022)

06062022@7 (Exp 09/04/2022)

06072022@3 (Exp 09/05/2022)

06072022@4 (Exp 09/05/2022)

06082022@1 (Exp 09/06/2022)

06082022@2 (Exp 09/06/2022)

06082022@4 (Exp 09/06/2022)

06102022@8 (Exp 09/08/2022)

06132022@1 (Exp 09/11/2022)

06132022@7 (Exp 09/11/2022)

06132022@14 (Exp 09/11/2022)

06132022@15 (Exp 09/11/2022)

06142022@7 (Exp 09/12/2022)

06142022@8 (Exp 09/12/2022)

06142022@15 (Exp 09/12/2022)

06152022@2 (Exp 09/13/2022)

06172022@4 (Exp 09/15/2022)

06202022@9 (Exp 09/18/2022)

06202022@10 (Exp 09/18/2022)

06202022@23 (Exp 09/18/2022)

06212022@2 (Exp 09/19/2022)

06222022@2 (Exp 09/20/2022)

06222022@3 (Exp 09/20/2022)

06242022@4 (Exp 09/22/2022)

06242022@5 (Exp 09/22/2022)

06272022@3 (Exp 09/25/2022)

06292022@5 (Exp 09/27/2022)

06292022@6 (Exp 09/27/2022)

07012022@11 (Exp 09/29/2022)

07012022@12 (Exp 09/29/2022)

07052022@3 (Exp 10/03/2022)

07052022@4 (Exp 10/03/2022)

07062022@4 (Exp 10/04/2022)

07062022@5 (Exp 10/04/2022)

07062022@10 (Exp 10/04/2022)

07082022@4 (Exp 10/06/2022)

07082022@5 (Exp 10/06/2022)

07092022@12 (Exp 10/07/2022)

07092022@13 (Exp 10/07/2022)

07112022@16 (Exp 10/09/2022)

07112022@17 (Exp 10/09/2022)

07122022@14 (Exp 10/10/2022)

07122022@15 (Exp 10/10/2022)

07132022@5 (Exp 10/11/2022)

07152022@11 (Exp 10/13/2022)

07152022@12 (Exp 10/13/2022)

Product: TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable (12.6 ML)

Variants: 12.6 ML vial, Rx only

Lot Numbers:

07052022@1 (Exp 10/08/2022)

Product: TRI-MIX 30/1/10 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

06282022@1 (Exp 08/27/2022)

06292022@8 (Exp 08/28/2022)

07012022@19 (Exp 08/30/2022)

07012022@3 (Exp 08/30/2022)

07122022@8 (Exp 09/10/2022)

07132022@9 (Exp 09/11/2022)

07192022@1 (Exp 09/17/2022)

07292022@9 (Exp 09/27/2022)

08032022@10 (Exp 10/02/2022)

08092022@2 (Exp 10/08/2022)

08102022@1 (Exp 10/09/2022)

08102022@6 (Exp 10/09/2022)

08102022@7 (Exp 10/09/2022)

08152022@5 (Exp 10/14/2022)

08192022@1 (Exp 10/18/2022)

08192022@10 (Exp 10/18/2022)

Product: TRI-MIX 30/1/20 Injectable (5 ML)

Variants: 5 ML vial, Rx only

Lot Numbers:

06272022@6 (Exp 08/26/2022)

07212022@3 (Exp 09/19/2022)

07292022@11 (Exp 09/27/2022)

08052022@7 (Exp 10/04/2022)

08102022@5 (Exp 10/09/2022)

08122022@14 (Exp 10/11/2022)

08172022@7 (Exp 10/16/2022)

Product: TRI-MIX 30/1/40 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

07052022@8 (Exp 09/03/2022)

07292022@10 (Exp 09/27/2022)

Product: TRI-MIX 30/1/60 Injectable (5 ML)

Variants: 5 ML vial, Rx only

Lot Numbers:

07012022@6 (Exp 09/20/2022)

07192022@16 (Exp 09/17/2022)

07012022@4 (Exp 08/30/2022)

Product: TRI-MIX 30/2/20 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

07052022@10 (Exp 09/03/2022)

07052022@16 (Exp 09/03/2022)

07122022@11 (Exp 09/08/2022)

07182022@17 (Exp 09/16/2022)

07202022@6 (Exp 09/18/2022)

07252022@9 (Exp 09/23/2022)

0729202222@2 (Exp 09/27/2022)

07292022@13 (Exp 09/27/2022)

08122022@9 (Exp 10/11/2022)

08162022@2 (Exp 10/15/2022)

082620222@1 (Exp 10/25/2022)

Product: TRI-MIX 30/2/40 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

07152022@4 (Exp 09/13/2022)

08152022@15 (Exp 10/14/2022)

Product: TRI-MIX 50/2.5/25 Injectable (2 ML)

Variants: 2 ML vial, Rx only

Lot Numbers:

07052022@2 (Exp 09/03/2022)

Product: QUAD-MIX 30/2/60/0.15 Injectable (5 ML)

Variants: 5 ML vial, Rx only

Lot Numbers:

08022022@12 (Exp 10/01/2022)

Product: QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable (10 ML)

Variants: 10 ML vial, Rx only

Lot Numbers:

08082022@3 (Exp 10/07/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90798

Status: Resolved

Manufacturer: Carolina Infusion

Sold By: Carolina Infusion LLC

Manufactured In: United States

Distributed To: Nationwide