CNNMoney.com Senior Writer Parija Kavilanz reported on May 25th on the Food and Drug Administration investigation into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson.
McNeil is also under a Congressional investigation regarding the recall, the House Committee on Oversight and Government Reform has scheduled a hearing on May 27th to examine the recall.
Highlights from the report include:
• Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.
• The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.
• Following the most recent recall, Johnson & Johnson (JNJ, Fortune 500) has suspended production at McNeil's facility in Fort Washington, Penn., that manufactured the children's drugs.
• The FDA, which earlier this month issued a scathing 17-page inspection report listing 20 violations at the Fort Washington plant, also maintains that the recalled drugs pose a "remote" potential for serious health problems.
• McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.
McNeil's latest recall is its fourth in the past seven months:
• In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
• In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
• In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.
Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.
In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.
• In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
• In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.
Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.
In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.
To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.
To view the CNNMoney.com story, visit: http://money.cnn.com/2010/05/25/news/companies/tylenol_recall_adverse_consumer_complaints/index.htm.
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