February 2014 FDA Recall Drug by Medisca Inc
D-0674-2016 - Labeling

This Class I drug recall was voluntarily initiated by Medisca Inc on February 14, 2014 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0674-2016

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.
Initiated
02-14-2014
Reported
02-24-2016
Quantity
25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67531
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medisca Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Australia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-17-2016
Product Description About Product Description
Full technical description of the 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).

Batch or Lot Expiration Information

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