May 2016 FDA Recall Drug by Attix Pharmaceuticals Inc
D-1047-2016 - cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration

This Class III drug recall was voluntarily initiated by Attix Pharmaceuticals Inc on May 18, 2016 for the product Drug. The FDA reported the reason for recall as cgmp deviation; manufacturer is not registered with the food and drug administration. The product was distributed in CO and the recall is currently terminated.

Recall Number: D-1047-2016

Reason for Recall
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Initiated
05-18-2016
Reported
06-29-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74361
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Attix Pharmaceuticals 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-26-2016
Product Description About Product Description
Full technical description of the product.
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada

Batch or Lot Expiration Information

Lot# Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017