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Recall Observatory FDA recall evidence

Drug product

2-Methoxyestradiol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

D-498-2015

November 14, 2014

Class II

Product summary

Firm
Attix Pharmaceuticals
Event
Event 70452
Status
Terminated
Classification
Class II
Quantity
90 grams
Official record key
drug-enforcement:D-498-2015

Official wording

Reason: 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.

Code information: All lots repackaged and distributed between 01/05/12 to 02/12/15

Distribution pattern: Nationwide to compounding pharmacies and research organizations.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    cross contamination with penicillin