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Recall: All Lots of All Sterile Products Compounded, Repackaged and Distributed By Green Valley Drugs -- Quality Control Concerns

Missouriwatcher

Editor, Senior Moderator
April 5, 2013 - Henderson, NV, Green Valley Drugs is voluntarily recalling All Lots of All Sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. A full list of the recalled products is attached to this press release and can be accessed at http://www.greenvalleymed.com/wp-content/uploads/2013/04/Green-Valley-Recall-Statement-FINAL.pdf. The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques.

Green Valley has received no reports of injury or illness associated with the use of our sterile products. In addition, we have received no indications of endotoxins or sterility issues from independent outside testing laboratories associated with any of the products subject to this recall. Out of an abundance of caution and in the interest of our patients, Green Valley Drugs has decided to voluntarily proceed with this recall process.

In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections.

Green Valley Drugs sterile products covered under this recall were distributed nationwide. Until further notice, health care providers should stop using all lots of sterile products and return them to the company.
http://www.fda.gov/Safety/Recalls/ucm347559.htm
 
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