RecallDepth
Class I Terminated

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).

This recall has been terminated (originally issued February 24, 2016).

Company
Medisca, Inc.
Recall Initiated
February 14, 2014
Posted
February 24, 2016
Recall Number
D-0674-2016
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles
Firm Location
Plattsburgh, NY, United States
Official Source
View on FDA website ↗

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

Nationwide and Australia

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

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