Green Valley Drugs has recalled 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 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 says it has received no reports of injury or illness associated with the use of its sterile products. In addition, the company says it has received no indications of endotoxins or sterility issues from independent outside testing laboratories associated with any of the products subject to this recall. 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 1-702-564-2079 Monday through Friday between the hours of 9 a.m. to 5 p.m. PDT, or e-mail email@example.com. Patients who have received any product distributed by Green Valley Drugs and have concerns should contact their health care 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, FAX or online. Go to www.fda.gov/medwatch/report.htm. When using regular mail use the postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form.
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