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Drug Information Update- FDA alerts that Medisca is voluntarily recalling certain lots of its L-citrulline product after testing indicated that it does not contain any L-citrulline

FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

FDA is alerting health care professionals, patients, and caregivers that Medisca Inc.’s testing of L-citrulline, lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D, indicated the product does not contain L-citrulline and should not be used by patients. Medisca is voluntarily recalling these lots:

  • 1 kg size: Lot #s 96453/A and 95482/A in 2.8 L white HDPE bottles;
  • 500 g size: Lot #s 96453/B and 95482/B in 1000 mL white HDPE bottles;
  • 100 g size: Lot #s 96453/C and 95482/C in 300 mL white HDPE bottles;
  • 25 g size: Lots #s 96453/D and 95482/D in 100 mL white HDPE bottles.
L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children. FDA recommends that pharmacists and clinic staff who dispense L-citrulline immediately examine their stock to determine if they have the affected lots and should contact Medisca for recall instructions at 1.800.932.1039 Monday to Friday from 8 a.m. to 7 p.m. EST.
 
FDA continues to investigate the full scope of this issue and will continue to provide additional information as it becomes available. To view the original FDA statement in full, please visit: Medisca.

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