D-0674-2016 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 24, 2016
- Initiation Date
- February 14, 2014
- Termination Date
- February 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles
Product Description
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).
Reason for Recall
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.
Distribution Pattern
Nationwide and Australia
Code Information
Lot #s: 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D, Exp. 10/31/2014