The Recall Desk
LowFDA (Drugs)·D-1047-2016·Announced 2016-06-29

Attix Pharmaceuticals Recalls Unregistered Mycophenolate Mofetil Bulk Powder

Attix Pharmaceuticals is recalling Mycophenolate Mofetil bulk powder due to cGMP deviations and lack of FDA registration.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

Plain-English summary

Attix Pharmaceuticals Inc is recalling Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g. The product is intended for prescription compounding use and medical manufacturing or processing only. The specific lot number is A3160A, with manufacturer batch number 151201 and an expiry date of November 2017.

The recall was initiated because of a Current Good Manufacturing Practice (cGMP) deviation. Additionally, the manufacturer is not registered with the U.S. Food and Drug Administration. The agency has classified this recall as Class III.

This recall affects the distribution of the product in Colorado. Consumers and healthcare providers should stop using the affected product and contact their supplier or the recalling firm for further instructions.

The recalled product

Product
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
Manufacturer
Attix Pharmaceuticals Inc
Category
Drug — Bulk Powder
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot Number: A3160A
  • Manufacturer batch number: 151201
  • Expiry November 2017

Distribution

Distributed in 1 state:

Related recalls

Same hazard · cGMP deviation

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