FDA recall D-0674-2016

Medisca Inc · Class I · drug

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).

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

Key facts

Status
Terminated
Initiation date
2014-02-14
Report date
2016-02-24
Termination date
2016-02-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plattsburgh, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0674-2016