FDA Announces Recall of L-citrulline, Supplement for Genetic Disorder

On Saturday, the U.S. Food and Drug Administration (FDA) said certain lots of the supplement L-citrulline, used to treat certain genetic disorders found mostly in children, were found not to contain any of the drug, and the agency warned doctors and patients not to use it. L-citrulline is produced by the compounding firm Medisca, Inc.

Medisca is voluntarily recalling eight lots of the supplement. The FDA said it has received “several adverse event reports associated with Medisca’s L-citrulline product,” according to Reuters. “Health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca Inc. Patients and caregivers should stop using any product with these lot numbers,” the FDA safety alert said. When patients with particular urea cycle defects take subpotent L-citrulline, this can lead to high ammonia levels in the blood, a serious and potentially life-threatening condition.

Testing by Medisca indicated that lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D of the supplement did not contain L-citrulline, according to the FDA. The company’s statement said that its investigation of the lots found that they did not contain L-citrulline “and therefore represent a potential health hazard. These lots should not be used for any purpose.” The FDA recommends that health care professionals quarantine lots of L-citrulline from Medisca and not administer to patients until the FDA provides additional information.

Medisca, a chemical compounding firm, supplies L-citrulline powder to pharmacies nationwide. The powder may be compounded into tablets, capsules, or liquids by pharmacies, or remain a powder. L-citrulline used for the treatment of urea cycle disorders is a pharmaceutical-grade preparation, not the over-the-counter supplement used by body builders, according to the National Urea Cycle Disorders Foundation.

Patients should contact a doctor if they have concerns about the use of L-citrulline. Doctors, patients, and caregivers may submit adverse event reports to the FDA online at www.fda.gov/medwatch/report.htm.