FDA Concerns Over Testing Co. Trigger Compounder Recalls

Law360, New York (August 28, 2013, 7:00 PM EDT) -- Two compounding pharmacies are recalling products after federal regulators encountered problems with sterility testing by a contractor that serves more than 100 compounders across the country, the U.S. Food and Drug Administration said Tuesday.

Both recalls involved specialty drugs tested by Colorado-based Front Range Laboratories Inc., which, according to the FDA, is used by compounders in 32 states to verify purity and quality.

While no reports of patient harm have emerged, the FDA said it couldn’t rule out the prospect of microbial contamination in the recalled...
To view the full article, register now.