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June 6, 2013
The essential resource for your practice
Volume XXI, Number 6
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FDA Issues Alert on NuVision Products

Recently the Food and Drug Administration (FDA) issued and then expanded an alert to healthcare providers concerning a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, TX. This compounding pharmacy produces an array of products including several used for treatment of urologic conditions.

The safety alert began in April with recalls for Methylcobalamin injection and lyophilized injection products but in May was expanded to all “sterile drug products made and distributed by NuVision” because FDA “investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company’s sterile drug products” during an inspection. Additionally, the FDA said “it received adverse event reports of fever, influenza-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product that was previously recalled.”

As part of its mission, the AUA’s Quality Department will continue to track FDA actions on compounding pharmacies and other aspects and will alert AUA members of issues and concerns; however, the AUA also urges its members to monitor FDA safety alerts as well, especially if a practice prescribes drugs from a compounding pharmacy.  The FDA offers a series of ways for both providers and the public to stay abreast of such safety alerts. One such mechanism designed for healthcare professionals is Medwatch; check out the FDA website for others.