Federal drug regulators issued a strong warning on Saturday, urging pharmacies and patients not to use certain lots of the supplement L-citrulline, following the discovery that may contain the incorrect ingredients.
Medisca, Inc. issued a L-citrulline recall (PDF) last week that affects eight lots, after product testing revealed that the supplement does not contain L-citrulline at all, instead containing N-acetyl-leucine, which is used to treat vertigo-associated dizziness.
In a statement issued February 14, the FDA cited the potential for serious side effects from taking “subpotent” doses of the supplement, indicating that several adverse event reports have been received concerning problems with the supplement.
Although details of the adverse events have not been released, the FDA warning insisted taking the recalled L-citrulline may result in “serious and potentially life-threatening” situations.
L-citrulline is often used to treat urea cycle disorders, a rare genetic disorder diagnosed in children. The disorder causes a deficiency of one of the six enzymes that help clear ammonia from the blood. An excess of ammonia in the blood can result in irreversible brain damage, coma and death.
The recall involves eight lots lots of the supplement sold in 1 kg size 2.8 L white HDPE bottles with lot numbers 96453/A and 95482/A, 500 g size 1000 mL white HDPE bottles lot numbers 96453/B and 95482/B, 100 g size 300 mL white HDPE bottles lot numbers 96453/C and 95482/C, and 25g size 100 mL white HDPE bottles lot numbers 96453/D and 95482/D.
The product is sold in containers filled with powdered L-citrulline. The powder then can be compounded into tablets, capsules or liquids by a pharmacy or it can remain as a powder and be taken in that form.
The agency has also indicated it is currently investigation reports of adverse events associated with additional lots of the product, but have not reached any further conclusions.
The FDA recommends health care professionals return unused lots of L-citrulline to the Plattsburg, New York based manufacturer, Medisca. Customers with questions can call (800) 932-1039