NuVision Pharmacy Announces Voluntary Nationwide Recall of All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns
Mon, 15 Apr 2013 23:17:00 -0400
Contact:800-914-7435FOR IMMEDIATE RELEASE - April 15, 2013 - NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections. To date, NuVision Pharmacy has received no reports of injury or illness associated with the use of our sterile products. However, out of abundance of caution and in the interest of our patients, NuVision Pharmacy has decided to voluntarily proceed with this recall process.These products were supplied to the offices of licensed medical professionals. NuVision Pharmacy’s sterile products covered under this recall were distributed nationwide. NuVision Pharmacy is notifying its customers by fax or email to return the products to the pharmacy. Consumers or Health Care providers with questions regarding this recall may contact NuVision Pharmacy by phone at 800-914-7435 on Monday through Friday from the hours of 10 am to 6 pm CST, or by e-mail at firstname.lastname@example.org. Patients who have received any product distributed by NuVision Pharmacy and have concerns should contact their healthcare provider.Adverse reactions or quality problems experienced with the use of any of the recalled drugs 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.htmRegular 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-0178This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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