Tuesday, October 22, 2013

Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns

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.

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348156.htm