It is a supplement used to treat children with a genetic disorder but instead has hospitalized at least one child. The Food and Drug Administration (FDA) reports lots of L-citrulline, sold by Medisca, had none of the active drug.
The Plattsburgh, N.Y.-based compounding company was forced to recall eight lots of the supplement. Instead of L-citrulline, the lots contained N-acetyl-leucine, a drug used to treat vertigo. Medisca is the nation’s primary supplier of L-citrulline, which is sold as a powdered supplement.
Children take the supplement to lower the amount of urea in the body which builds up in individuals who are missing six enzymes that normally clear ammonia from the blood. Without the supplement, an ammonia buildup can cause brain damage and can be fatal.
The National Urea Cycle Disorders Foundation of Pasadena, California reports at least six children had taken the supplement and reported problems. One girl was hospitalized due to the high levels of ammonia accruing in her system.
The genetic disorder affects upward of 2,500 U.S. children, and three-quarters take the L-citrulline supplement, reports NBC News.
Medisca has been fined in the past for selling human growth hormone from China, which is illegal.
The contaminated lots were sent to hospitals and pharmacies across the U.S. though it has not been tracked to identify which facilities received the lots.
Consumers are urged to contact their health care providers if they have the product and are concerned about its purity. The FDA has the affected lot numbers listed on its website and is asking the products be returned to Medisca.
After the New England Compounding Center released a fungal meningitis-tainted steroid in 2012 and 64 individuals lost their lives, the FDA tightened up the oversight of compounding pharmacies. Typically the pharmacies, which make small batches of specially formulated drugs, have fallen somewhere between FDA and state oversight or, in many cases, were operating with no regulations at all.
Ever since January, all compounding pharmacies were supposed to register with the FDA, as Medisca did this year.