Recalls / Class I

Class ID-0674-2016

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).

Affected lot / code info: Lot #s: 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D, Exp. 10/31/2014

Why it was recalled

Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.

Recalling firm

Firm: Medisca Inc
Notification channel: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type: Voluntary: Firm initiated
Address: 661 State Route 3, Unit C, Plattsburgh, New York 12901-6531

Distribution

Quantity: 25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles
Distribution pattern: Nationwide and Australia

Timeline

Recall initiated: 2014-02-14
FDA classified: 2016-02-17
Posted by FDA: 2016-02-24
Terminated: 2016-02-17
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0674-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.