CLASS III Drug recall · Reported 29 Jun 2016 · FDA Enforcement Report
Mycophenolate Mofetil, Bulk Powder, Quantity recalled
Attix Pharmaceuticals is recalling Mycophenolate Mofetil, Bulk Powder, Quantity, For prescription compounding use and, distributed in Colorado. The recall was initiated on 18 May 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1047-2016
- FDA event ID
- 74361
- Recalling firm
- Attix Pharmaceuticals, Toronto, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 May 2016
- FDA classified
- 21 Jun 2016
- Reported
- 29 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Compounded Drugs
Timeline
| 18 May 2016 | Recall initiated by company | |
| 21 Jun 2016 | Classified by FDA | +34 days |
| 29 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Product as listed by the FDA
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
Where it was distributed
CO
Questions about this recall
Is Mycophenolate Mofetil, Bulk Powder, Quantity, For prescription compounding use and recalled?
Yes. Attix Pharmaceuticals recalled Mycophenolate Mofetil, Bulk Powder, Quantity, For prescription compounding use and on 18 May 2016. The recall is Class III and its status is Terminated. Recall number D-1047-2016.
Why was it recalled?
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Which lots are affected?
Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017
Where was it sold?
CO
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Miltefosine active pharmaceutical ingredient recalled | Attix Pharmaceuticals | Packaging Defects | Nationwide |
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