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Recall Observatory FDA recall evidence

Drug product

Amoxicillin Trihydrate 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-520-2015

November 14, 2014

Class II

Product summary

Firm
Attix Pharmaceuticals
Event
Event 70452
Status
Terminated
Classification
Class II
Quantity
100 grams
Official record key
drug-enforcement:D-520-2015

Official wording

Reason: Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 through 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.

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

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry