FDA warns against sterile products from NuVision compounding pharmacy

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108c7eac26bd12977cb0333539f93af4In April of this year, the Food and Drug Administration (FDA) issued an alert about products shipped from NuVision Pharmacy of Dallas because of poor sterile production practices. The compounding pharmacy has since refused to recall drugs considered potentially tainted by the FDA. Because of this, the FDA urges health care providers not to use any sterile products shipped from NuVision.

The FDA does not have the authority to require NuVision to issue a recall of the products. However, they warn that when a drug product marketed as sterile contains microbial contamination, "patients could be at risk for serious, potentially life-threatening infections.

In April, NuVision did recall some of their methylcobalamin (vitamin B12) products because there were reports of fever, flu-like symptoms, and injection-site pain associated with the product. But according to the FDA, the agency is not aware of any adverse event reports associated with other sterile products from NuVision.

Dr. Ruth Kava observed, This FDA warning is directed at health-care providers, not patients. While we have seen problems with products sourced from compounding pharmacies in the recent past, meaning of course the horrendous fungal contamination last year at the New England Compounding Center which sickened hundreds and killed dozens, this advisory has little to do with that it s really a consciousness-raising action on the part of the FDA in my opinion, likely because no actual contamination nor patient harm has been detected as of now.