Drugs

FDA lab testing finds N-acetyl-leucine in samples of recalled Medisca product labeled as L-citrulline

[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 MedWatch Adverse Event Reporting program:


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 its 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.
  • Medisca is voluntarily recalling 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. 
  • Patients should contact their health care professional if they have concerns.
  • FDA has received several adverse event reports associated with Medisca’s L-citrulline product. FDA is investigating reports that may include additional lot numbers.
[2/15/2014] 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.
 
FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:


FDA alerts health care professionals and patients of severe adverse events associated with L-citrulline repackaged by Medisca

[2/14/2014] The U.S. Food and Drug Administration is alerting health care professionals, patients, and caregivers of adverse events reported in patients who were administered L-citrulline repackaged and distributed by Medisca Inc., Plattsburg, N.Y. FDA has received several adverse event reports associated with potentially subpotent L-citrulline with lot number 96453. FDA is investigating reports that may include additional lot numbers.

FDA recommends health care professionals quarantine lots of L-citrulline from Medisca and not administer to patients until FDA provides additional information. L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children. Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.

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.

FDA and Medisca are investigating this issue and will provide additional information as it becomes available.

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 companies, including Medisca, to the FDA’s MedWatch Adverse Event Reporting program:

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Page Last Updated: 12/09/2014
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