Agency classClass IIOur severity:High FDA (Drugs)·D-1515-2022·Announced 2022-09-21

L-Carnitine Injectable Recalled Due to Sterility Assurance Failure

Carolina Infusion is recalling L-Carnitine 500 mg/mL injectable vials nationwide due to lack of assurance of sterility. The affected lot 06132022@17 should not be administered.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 Class II drug recall for a high-risk injectable product with lack of assured sterility. No illnesses or injuries are reported in the source, so per the rubric, the score is at most 3 for a risk-of-harm product where no injury has yet been reported.

Plain-English summary

Carolina Infusion LLC is recalling L-Carnitine 500 mg/mL injectable in 10 mL vials due to lack of assurance of sterility. The affected lot number is 06132022@17, with a Beyond Use Date of February 15, 2023. The product was distributed nationwide in the United States.

Lack of assurance of sterility means the manufacturer cannot confirm that the product has been manufactured and handled in a manner that ensures freedom from contamination. For injectable medications, this is a critical concern.

Healthcare providers who have this product should immediately cease use of the affected lot. Patients who have received this medication should contact their healthcare provider about the recall.

The recalled product

Product: L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable medication
Hazard: sterility-failure
contamination-risk
Affected units: 1

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)

Lot: 06132022@17
BUD: 02/15/2023

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 →

Same manufacturer · Carolina Infusion

See all →

High
Injectable Steroid Product Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
High
Injectable testosterone product recalled for sterility assurance defect
FDA (Drugs) · 2022-09-21
High
Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
High
Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
High
TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance
FDA (Drugs) · 2022-09-21

Same hazard · sterility failure