FDA Warns Sun Over Oxycodone Quality Control Issues

Law360, New York (September 1, 2010, 5:23 PM EDT) -- The U.S. Food and Drug Administration has faulted a unit of Sun Pharma Global Inc. for lapses in quality control the regulator blames for “imploding” bottles of gemfibrozil, “sweating” nimodipine capsules and misplaced oxycodone pills.

The FDA said that Sun Pharmaceutical Industries Inc. had failed to address almost 20 consumer complaints and maintained insufficient quality controls at its Cranbury, N.J., manufacturing facility, according to an Aug. 25 letter made public Monday.

Multiple lots of packages of gemfibrozil, a lipid-reducing drug, imploded in the facility's sample room,...
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