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Recall Observatory FDA recall evidence

Drug product

BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24

D-0224-2019

October 31, 2018

Class II

Product summary

Firm
Avella of Deer Valley, Inc. Store 38
Event
Event 81466
Status
Terminated
Classification
Class II
Quantity
911 syringes
Official record key
drug-enforcement:D-0224-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot # 138-20182408@58 BUD 12/22/2018

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility