Recalls / Class II

Class IID-0177-2015

Product

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

Affected lot / code info

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.

Why it was recalled

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.

Recalling firm

Firm

Oregon Compounding Centers, Inc. dba Creative Compounds

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

8560 Sw Salish Ln Ste 100, N/A, Wilsonville, Oregon 97070-9625

Distribution

Quantity

5483/0.5 mL syringes

Distribution pattern

Oregon, Washington

Timeline

Recall initiated

2014-10-06

FDA classified

2014-10-31

Posted by FDA

2014-11-12

Terminated

2015-06-30

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0177-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.