Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Mycophenolate Mofetil
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
Drug: Phenol
- Recalling firm
- Attix Pharmaceuticals Inc
- Origin
- N/A, Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1047-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenol recalls
See all
Class II · Moderate risk
Class II · Moderate risk
Unguentine Original Ointment for Burns
CGMP DEVIATIONS
Class II · Moderate risk
Phenol 10%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Phenol
CGMP Deviations
Other recalls by Attix Pharmaceuticals Inc
All 2016 recalls
Class II · Moderate risk
Zonisamide active pharmaceutical ingredient packaged in varying…
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Class II · Moderate risk
Zolmitriptan active pharmaceutical ingredient packaged in varying…
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Class II · Moderate risk
Zoledronic Acid active pharmaceutical ingredient packaged in…
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Class II · Moderate risk
Zinc Pyrithione active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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