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A Congressional hearing set to begin today will look into a Pennsylvania drug plant plagued with quality control problems that resulted in a massive nationwide recall of children’s Tylenol as well as dozens of other pediatric medicines, including Motrin, Zyrtec and Benadryl. The Fort Washington Plant, in suburban Philadelphia, is run by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson. At the heart of the plant’s problems may be a drastic cutback in qualified employees over the years. It has been reported that the reduction in employees came about as Johnson & Johnson sought to cut costs during the recession, but the action may have also caused a drastic reduction in quality.
The FDA inspected the plant earlier this year and found that the company had failed to properly train contract and temporary workers. The FDA also found bacterial contamination of raw materials, poor equipment maintenance, and failure to investigate 46 consumer complaints about problems with black specks and foreign materials in medicines that began rolling in nearly a year before the recall. Medicines were recalled for having tiny metallic specks in them and others for medication errors where the pills contained higher than recommended dosages.
It has been reported that the FDA has received several hundred complaints of illnesses that occurred after taking the recalled medicine, including seven deaths. The FDA has not, at this point, conclusively linked the sicknesses or deaths to the recalled medicines.
The April 30 drug recall is the fourth since September involving adult or children’s Tylenol, and the FDA has expanded its investigations to a McNeil plant in Lancaster, Pennsylvania as well as one in Las Piedras, Puerto Rico. Consumers have complained that medicines manufactured at the Puerto Rico plant had sickening odors and had caused illness, perhaps due to mold or other contamination.