The Recall Desk
HighFDA (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.

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 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

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.

Related recalls

Same category