Are you a legal professional? Visit our professional site

FDA Wants Texas Compounding Pharmacy to Recall Products

Article Placeholder Image
By Admin on September 10, 2014 1:35 PM

The Food and Drug Administration is redoubling efforts to crack down on a Texas compounding pharmacy it has repeatedly accused of producing contaminated medicines.

The FDA issued a formal request that Downing Labs, which operates the the Dallas-based NuVision Pharmacy, recall all of its sterile products after an inspection performed this summer found numerous problems with the facility reports The Wall Street Journal.

Inspection Uncovered 'At Least 19' Contaminated Drug Lots

According to a letter sent by the FDA to Downing Labs requesting the recall last week, inspections of the Dallas facility this summer found that at least 19 lots of supposedly sterile drugs produced at the facility tested positive for microbial contamination and three more failed tests for bacterial endotoxin. According to the FDA, this means "there is a high probability that contaminated units from other purportedly sterile drug product lots produced at the Downing Labs facility are currently in distribution."

The FDA warns that being given a non-sterile drug that is intended to be sterile can cause infection, permanent organ damage, or even death.

Compounding Pharmacies in the News

Compounding pharmacies have faced increased scrutiny after steroids contaminated with fungus distributed by a Massachusetts compounding pharmacy was linked to at least 64 deaths.

In that case, a pharmacist at New England Compounding Center was arrested and accused of instructing pharmacy technicians to label medication as properly sterilized and tested when it hadn't been. The fungal meningitis outbreak also led to a number of civil lawsuits, which resulted a $100 million settlement reached earlier this year.

FDA's Recall Power

The FDA is requesting that Downing Labs recall its products, but is unable to force them to do so, as it admitted in a news release following a previous warning about the company's products.

Even following the passage of last year's Compounding Quality Act, which implemented a voluntary registration program for compounding facilities, the FDA currently lacks the power to compel a mandatory recall of the drugs produced by NuVision.

Related Resources: