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

Recall Insight

This FDA Drug action (record #D-1047-2016) was formally reported on June 29, 2016, with the manufacturer initiating the action on May 18, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Attix Pharmaceuticals Inc is listed as the recalling firm, operating out of Toronto, N/A. Federal records indicate N/A units are affected.

The documented reason for this recall is: cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration Distribution data in the federal record shows the product reached: CO. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.