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Recall Observatory FDA recall evidence

Drug product

Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684

D-1058-2013

September 09, 2013

Class II

Product summary

Firm
Avella of Deer Valley, Inc.
Event
Event 66210
Status
Terminated
Classification
Class II
Quantity
750 units
Official record key
drug-enforcement:D-1058-2013

Official wording

Reason: Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.

Code information: 12-20130508@179, Exp 11/3/2013

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility