UPDATED 02/17/2014. FDA has tested samples from recalled lots of Medisca’s L-citrulline product, and were analyzed by several laboratory methods to identify the ingredient that was repackaged by Medisca and labeled as L-citrulline. FDA has found that the samples contain N-acetyl-leucine, which is used to treat a certain type of dizziness (acute vestibular vertigo). No L-citrulline was found in the samples FDA tested.
UPDATED 02/15/2014. FDA alerts health care professionals and patients that Medisca is voluntarily recalling certain lots of its L-citrulline product after testing indicated that it does not contain any L-citrulline
- Testing by Medisca indicated that L-citrulline, lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D do not contain L-citrulline. Pharmacists should see updated FDA Statement below for more product details.
- Medisca is voluntarily recalling all L-citrulline product with the above lot numbers.
- 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.
- FDA has received several adverse event reports associated with Medisca’s L-citrulline product. FDA is investigating reports that may include additional lot numbers, continues to investigate the full scope of this issue and will continue to provide additional information as it becomes available.
AUDIENCE: Medical Geneticist, Pediatrics, Pharmacy
ISSUE: FDA is notifiying health care professionals, patients, and caregivers of adverse events reported in patients who were administered L-citrulline repackaged and distributed by Medisca Inc. L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children. FDA has received adverse event reports associated with potentially subpotent L-citrulline. Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.
In addition to the identified lot number 96453, FDA is investigating reports that may include additional lot numbers.
BACKGROUND: Medisca supplies pharmacies nationwide with L-citrulline. The product is sold to pharmacies and clinics in containers filled with powdered L-citrulline, and it may be compounded into tablets, capsules, or liquids by pharmacies, or remain a powder.
RECOMMENDATION: FDA recommends health care professionals quarantine lots of L-citrulline from Medisca and not administer to patients until FDA provides additional information.
Patients should contact their physician or health care provider if they have concerns about the use of L-citrulline.
FDA asks health care professionals, patients, and caregivers to report adverse reactions or quality problems experienced with the use of L-citrulline packed by any companies, including Medisca, to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the reporting form, then submit it via fax at 1-800-FDA-0178
[02/14/2014 - Statement - FDA]