Attix Recalls Mycophenolate Mofetil Bulk Powder Due to cGMP Deviations
Attix Pharmaceuticals recalls 1000g lots of Mycophenolate Mofetil bulk powder due to current Good Manufacturing Practice deviations and unregistered status.
Recall notice
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Contact the company
What happened, in plain English
Attix Pharmaceuticals Inc is recalling Mycophenolate Mofetil, Bulk Powder intended for prescription compounding and medical manufacturing. The recall stems from current Good Manufacturing Practice (cGMP) deviations and the fact that the manufacturer is not registered with the Food and Drug Administration. No specific remedy or action steps are listed in the record. Read more at govinfonow.com/recall/42607-attix-recalls-mycophenolate-mofetil-bulk-powder-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/42607-attix-recalls-mycophenolate-mofetil-bulk-powder-due-to-cgmp-deviations · Updated October 9, 2026 · FDA enforcement record: FDA #D-1047-2016
Cite this page
“Attix Recalls Mycophenolate Mofetil Bulk Powder Due to cGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42607-attix-recalls-mycophenolate-mofetil-bulk-powder-due-to-cgmp-deviations. Based on FDA recall #D-1047-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1047-2016%22&limit=1).
Why it’s dangerous
The product was manufactured with cGMP deviations, which can affect quality and safety standards. Additionally, the manufacturer is not registered with the FDA, raising concerns about oversight and compliance.
Who’s affected
Entities involved in prescription compounding, medical manufacturing, or processing that purchased this bulk powder from Attix Pharmaceuticals. The record does not specify individual consumer risks beyond the regulatory violations.
How to tell if you have this one
Look for Mycophenolate Mofetil, Bulk Powder in 1000 g quantities. Check for Lot Number A3160A, Manufacturer batch number 151201, and an expiry date of November 2017. The product was distributed in Colorado.
- Brand
Attix Pharmaceuticals- Category
Drug
Where it went and when
Where it was distributed
Distributed in Colorado.
FDA distribution: “CO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado.
Recall timeline
FDA terminated this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1047-2016 (May 18, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1047-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.