Drug product
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
D-1047-2016
Product summary
- Event
- Event 74361
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-1047-2016
Official wording
Reason: cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Code information: Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017
Distribution pattern: CO
Derived failure modes
-
Manufacturing or process control
cGMP deviation