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FDA: Do not use sterile products from NuVision Pharmacy
Concerns over the safety of sterile drug products made and distributed by NuVision Pharmacy have prompted the U.S. Food and Drug Administration to issue a reminder to health care providers to avoid administering sterile products from the Dallas-based company.
The FDA requested an immediate recall of all lots of sterile NuVision-produced compounds that have not passed their expiration dates in late July, but NuVision has repeatedly declined to order the recall, according to an FDA news release.
Because the FDA could not order a recall, it instead issued the reminder to health care providers.
The recall request came as a result of investigators observing poor sterile production practices at the Dallas facility, according to the FDA release.
NuVision’s website notes its ophthalmologic pharmaceuticals division provides various preparations for diagnostic, therapeutic, anesthetic and pain-management needs.
The company also offers compounding for adrenal fatigue, anti-aging, auto-immune diseases, bioidentical hormone replacement therapy for men, bioidentical hormones, compounding flavors, dental, dermatological, erectile dysfunction, lyophilization, mesotherapy, nutritional blending, gynecological, pain management therapy, palliative care, pediatrics, phlebology, podiatry, proctology, sexual function, sports medicine and thyroid compounds.