PlainRecalls
FDA Drug Moderate Class II Terminated

BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

Reported: November 12, 2014 Initiated: October 6, 2014 #D-0178-2015

Product Description

BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

Reason for Recall

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.

Details

Units Affected
2.65 mL
Distribution
Oregon, Washington
Location
Wilsonville, OR

Frequently Asked Questions

What product was recalled?
BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.. Recalled by Oregon Compounding Centers, Inc. dba Creative Compounds. Units affected: 2.65 mL.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 12, 2014. Severity: Moderate. Recall number: D-0178-2015.