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Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: 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.
BACKGROUND: These products were supplied to the offices of licensed medical professionals. NuVision Pharmacy’s sterile products covered under this recall were distributed nationwide. 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.
RECOMMENDATION: 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 pharmacist@xxxxxxxxxxxxxxxxxxxx. Patients who have received any product distributed by NuVision Pharmacy 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 links to the Press Release and Recall at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348156.htm
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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