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Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns
AUDIENCE: Healthcare Professional, Consumer
ISSUE: Green Valley Drugs notified healthcare professionals and their organizations about the recall of 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 (name, lot # and Beyond Use date) is linked from the press release or can be accessed at greenvalleymed.com. Green Valley Drugs sterile products covered under this recall were distributed nationwide.
BACKGROUND: 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 the products.
RECOMMENDATIONS: Until further notice, healthcare providers should stop using all lots of sterile products and return them to the company. Consumers or healthcare providers with questions regarding this recall may contact Green Valley Drugs by phone at 702-564-2079 Monday through Friday between the hours of 9 am to 5 pm PST, or by e-mail at pharmacy@xxxxxxxxxxxxxxxxxx. Patients who have received any product distributed by Green Valley Drugs and have concerns should contact their healthcare provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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