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Recall Observatory FDA recall evidence

Drug product

Ticarcillin Sodium/Potassium Clavulanate (30:1) 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-929-2015

November 14, 2014

Class II

Product summary

Firm
Attix Pharmaceuticals
Event
Event 70452
Status
Terminated
Classification
Class II
Quantity
6000 grams
Official record key
drug-enforcement:D-929-2015

Official wording

Reason: Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 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