FDA: Medisca L-citrulline Product Recalled

February 2014

FDA: Medisca L-citrulline Product Recalled

The U.S. Food and Drug Administration (FDA) recently issued several public notifications regarding Medisca L-citrulline product.

Initially, the FDA alerted health care professionals and the public that adverse events were reported in patients who were given L-citrulline distributed by Medisca Inc. L-citrulline is used to treat urea cycle disorders, rare genetic disorders in children.

After testing the product, the FDA notified the public that Medisca is voluntarily recalling certain lots of its L-citrulline product as it does not contain any L-citrulline but rather N-acetyl-leucine, Test results indicated that 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.

Health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca Inc.

For more information, please visit www.fda.gov

References

  1. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com
  2. US Food and Drug Administration. www.fda.gov

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