FDA Warning: Drugs from NuVision May Not be Sterile

July 21, 2014 — Sterile products made by Downing Labs, LLC, also known as NuVision Pharmacy, should not be used because they may be contaminated, according to a Safety Alert from the U.S. Food and Drug Administration (FDA).

This is not the first time the FDA has found problems with NuVision. Last April, the FDA warned that certain drug products had a “high potential for contamination.”

At least six patients who received contaminated injections of methylcobalamin complained of fever, flu-like symptoms, chills, and soreness at the injection site. Although NuVision agreed to recall the methylocobalamin, they refused to recall other sterile products. The FDA cannot force NuVision to recall the products.

Most recently, inspectors for the FDA observed “insanitary” conditions and documented these failures in a 483 form issued on July 16, 2014. According to the FDA:

“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.”

Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other circulatory functions. The FDA has not received any reports of illness associated with the products. However, patients who receive a non-sterile medication could develop life-threatening infections or death.

In the last two years, the FDA has significantly stepped up their oversight of the compounding pharmacy industry. In 2012, contaminated medicines from one pharmacy in Massachusetts caused a massive outbreak of fungal meningitis that infected over 750 people in 20 states, including more than 60 who died.

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