FDAFDA · Food and drugs·Recall number D-0674-2016
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).
Published February 24, 2016 · Recall initiated: February 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medisca Inc
- Distributor
- Nationwide and Australia
- Lot
- Lot #s: 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D, Exp. 10/31/2014
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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