FDA recall D-1047-2016

Product

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

Reason for recall

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

Distribution

CO

Key facts

Status

Terminated

Initiation date

2016-05-18

Report date

2016-06-29

Termination date

2016-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1047-2016