Mycophenolate Mofetil recalled over manufacturing violations

Recall date

May 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Attix Pharmaceuticals Inc recalls Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or proc…

Recall number

D-1047-2016

FDA classification

Class III

Brand / firm

Attix Pharmaceuticals Inc

Sold / distributed

CO

Why it was recalled

cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada