[2/17/2014] FDA has tested samples from recalled lots of Medisca’s L-citrulline product, and 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.
The samples were analyzed by several laboratory methods to identify the
ingredient present in the product that was repackaged by Medisca and labeled as
L-citrulline.
These results reinforce the FDA’s concern about Medisca’s product labeled
as L-citrulline and serve to remind patients and clinics not to use any recalled
Medisca L-citrulline product with lot numbers 95482/A, 95482/B, 95482/C, 95482/D
and 96453/A, 96453/B, 96453/C, 96453/D.
We are updating FDA’s recommendation to health care professionals so that
they can focus their attention on following up with the patients who are
believed to be at greatest risk of receiving a mislabeled product.
FDA will continue to provide additional information as it becomes
available.
FDA asks health care professionals, patients, and
caregivers to report adverse events or quality problems experienced with the use
of L-citrulline to the FDA’s MedWatch1 Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm2
- Download and complete the form3, then submit it via fax at 1-800-FDA-0178