July 21, 2014 — The U.S. Food and Drug Administration (FDA) is warning healthcare professionals not to administer medications marketed as sterile by Downing Labs, LLC, also known as NuVision Pharmacy, because they may be contaminated.
The FDA also issued several warnings for NuVision Pharmacy last year. The agency received at least six adverse event reports from patients who experienced fever, flu-like symptoms, chills, and soreness after receiving injections of methylocobalamin.
The FDA warned about a “high potential for contamination” with certain products. Although NuVision recalled the methylocobalamin, they refused to recall other sterile medications.
On July 16, 2014, the FDA issued a 483 form documenting numerous failures that were observed during inspections, including evidence of “insanitary” conditions:
“The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures.”
Although there have been no adverse events linked to these products, certain bacteria produce endotoxins, which can cause fever, shock, changes in blood pressure or other circulatory functions, and a wide variety of other serious side effects.
The FDA recommends that patients who have received drugs produced by NuVision should contact their healthcare professional with any concerns.
NuVision is a compounding pharmacy based in Dallas, Texas. The FDA has stepped up inspections after a deadly outbreak of fungal meningitis in 2012, which infected over 750 people in 20 states. The outbreak was traced to one pharmacy in Massachusetts.
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