Contamination Concerns Land Raritan Pharmaceuticals a Form 483

February 1, 2013

Raritan Pharmaceuticals’ East Brunswick, N.J., plant received a one-page Form 483 regarding concerns that distributed lots of one of its consumer products might be contaminated with clostridium difficile bacteria.

The company was notified Aug. 21, 2012, that gelatin raw material used to manufacture different versions of the product may have been tainted with the bacteria, the FDA said.

Raritan launched an investigation, still ongoing at the time of the agency’s September 2012 inspection one week later. But despite the ongoing probe, at least 10 finished product lots using the potentially contaminated material were shipped to the market, according to the form.

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