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Recall Observatory FDA recall evidence

Drug product

AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

D-0177-2015

October 06, 2014

Class II

Product summary

Firm
Oregon Compounding Centers, Inc. dba Creative Compounds
Event
Event 69519
Status
Terminated
Classification
Class II
Quantity
5483/0.5 mL syringes
Official record key
drug-enforcement:D-0177-2015

Official wording

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information: Lot #: 20140715@13, discard date: 11/3/2014; Lot #: 20140716@25, discard date: 10/14/2014; Lot #: 20140717@7, discard date: 10/15/2014; Lot #: 20140724@14, discard date: 10/22/2014; Lot #: 20140724@15, discard date: 10/22/2014; Lot #: 20140729@11, discard date: 10/27/2014; Lot #: 20140801@17, discard date: 10/30/2014; Lot #: 20140805@1, discard date: 11/3/2014; Lot #: 20140807@13, discard date: 11/5/2014; Lot #: 20140811@30, discard date: 11/9/2014; Lot #: 20140813@10, discard date: 11/11/2014; Lot #: 20140825@8, discard date: 11/23/2014; Lot #: 20140904@46, discard date: 12/3/2014; Lot #: 20140909@12, discard date: 12/8/2014; Lot #: 20140909@21, discard date: 12/8/2014; Lot #: 20140912@30, discard date: 12/11/2014; Lot #: 20140917@11, discard date: 12/16/2014; Lot #: 20140917@9, discard date: 12/16/2014; Lot #: 20140922@30, discard date: 12/21/2014; Lot #: 20140814@15, discard date: 11/12/2014.

Distribution pattern: Oregon, Washington

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility