Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns

Date of Recall

2013-04-10

Recall Details

- 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 greenvalleymed.com. 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.

Consumers or Health Care providers with questions regarding this recall may contact Green Valley Drugs by phone at 702-564-2079 or e-mail address at [email protected]; Monday through Friday between the hours of 9 am to 5 pm PST. Patients who have received any product distributed by Green Valley Drugs and have concerns should contact their healthcare provider.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

List of Recalled Products

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