FDA Recall D-0674-2016

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).

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

Quantity: 25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles

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.

Recall record

Recall number

D-0674-2016

Classification

Class I

Status

Terminated

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution

Nationwide and Australia

Recall initiated

2014-02-14

Classified by FDA Center

2016-02-17

FDA published

2016-02-24

Terminated

2016-02-17

Recalling firm

Medisca Inc

Firm location

Plattsburgh, NY