Mycophenolate Mofetil Powder (Attix) – FDA Registration Issue (2016)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
Brand
Attix Pharmaceuticals Inc
Lot Codes / Batch Numbers
Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017
Products Sold
Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017
Attix Pharmaceuticals Inc is recalling Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical ma due to cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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Page updated: Jan 7, 2026