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Drug Information Update-FDA lab testing finds N-acetyl-leucine in samples of recalled Medisca product labeled as 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 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.

For more information please visit: Medisca

 


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