Recall Register

Food, drugs, devices

Drug recall: L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

FDA enforcement event 90798 · Class II · initiated 26 Aug 2022 · status Completed

DrugVoluntary: Firm initiated20 product recordsRidgeland, SC

an individual recalling firm (name withheld) (Ridgeland, SC) initiated this drug recall on 26 Aug 2022; FDA lists 20 product records under event 90798, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Completed. Initiation: voluntary: firm initiated.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Individual recalling firm (name withheld), Ridgeland, SC. FDA names an individual as the recalling firm; this site does not publish people's names.

Reason for recall

"Lack of Assurance of Sterility"

Distribution

"Nationwide in the USA."

Product records

Recall numberProductQuantityClassStatusReport date
D-1515-2022L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.1 vialClass IICompleted21 Sep 2022
D-1516-2022MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.3 vialsClass IICompleted21 Sep 2022
D-1517-2022MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.4 vialsClass IICompleted21 Sep 2022
D-1518-2022Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.8 syringesClass IICompleted21 Sep 2022
D-1519-2022Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.24 syringesClass IICompleted21 Sep 2022
D-1520-2022Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.4 syringesClass IICompleted21 Sep 2022
D-1521-2022Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.4 syringesClass IICompleted21 Sep 2022
D-1522-2022TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.2 vialsClass IICompleted21 Sep 2022
D-1523-2022TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.3 vialsClass IICompleted21 Sep 2022
D-1524-2022TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.348 vialsClass IICompleted21 Sep 2022
D-1525-2022TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.1 vialClass IICompleted21 Sep 2022
D-1526-2022TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.16 vialsClass IICompleted21 Sep 2022
D-1527-2022TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.7 vialsClass IICompleted21 Sep 2022
D-1528-2022TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.2 vialsClass IICompleted21 Sep 2022
D-1529-2022TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.3 vialsClass IICompleted21 Sep 2022
D-1530-2022TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.11 vialsClass IICompleted21 Sep 2022
D-1531-2022TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.2 vialsClass IICompleted21 Sep 2022
D-1532-2022TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.1 vialClass IICompleted21 Sep 2022
D-1533-2022QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.1 vialClass IICompleted21 Sep 2022
D-1534-2022QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.1 vialClass IICompleted21 Sep 2022

Context

65%of 2022 drug events are Class II325 events that year
20product records in this event
1event on this register for the firm

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of Assurance of Sterility"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide in the USA."

Is the recall still ongoing?

FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.