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Product Labeled With Wrong Drug Recalled Due to Injuries


The 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.

 

L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children.

 

Medisca voluntarily recalled certain lots of its L-citrulline product. The manufacturer’s own testing 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.

 

The FDA has received several adverse event reports associated with Medisca’s L-citrulline product. The FDA is investigating reports that may include additional lot numbers. The FDA continues to investigate the full scope of this issue and will continue to provide additional information as it becomes available.

 

See the FDA Announcement

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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