Attix Pharmaceuticals Mycophenolate Mofetil Recall: FDA Class III

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1047-2016
Classification: Class III
Status: Terminated
Recall initiated: May 18, 2016
FDA report date: Jun 29, 2016
Quantity: N/A
Recall type: Voluntary: Firm initiated
Recalling firm: Attix Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-1047-2016, exactly as published.

Show all FDA fields

City: Toronto
Status: Terminated
Country: Canada
Event ID: 74361
Address: 481 University Ave Unit 502
Code information: Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017
Report date: Jun 29, 2016
Product type: Drugs
Recall number: D-1047-2016
Classification: Class III
Recalling firm: Attix Pharmaceuticals Inc
Termination date: Jul 26, 2016
Reason for recall: cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Voluntary / mandated: Voluntary: Firm initiated
Product description: Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
Distribution pattern: CO
Recall initiation date: May 18, 2016
Initial firm notification: Telephone
Center classification date: Jun 21, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1047-2016, published Jun 29, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Attix Pharmaceuticals Mycophenolate Mofetil Recall

Summary