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Recall Observatory FDA recall evidence

Drug product

Crospovidone 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-602-2015

November 14, 2014

Class II

Product summary

Firm
Attix Pharmaceuticals
Event
Event 70452
Status
Terminated
Classification
Class II
Quantity
10500 grams
Official record key
drug-enforcement:D-602-2015

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