Included in those reports were 30 deaths, nearly all of which were not linked to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to a source close to the investigation, CNNMoney.com reports.
The FDA is also investigating reports of several hundred serious side effects or "adverse events," and seven deaths since April 30, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns, according to the CNN report.
Adverse events, which the FDA describes as complaints of a serious side effect associated with the use of a medical product, may include death, hospitalization, disability and other health complications.According to the report, 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.
The manufacturing facility apparently wasn't checking its products for bacteria, properly testing its batches, safely storing materials and labels and was in general disarray, inspectors said. Overall, quality control was found to be virtually non-existent.
Those details emerged as the FDA again urged consumers to halt using the products and to shift to alternatives. Generic versions of the over-the-counter products are not affected by this recall and are considered safe.
The House Committee on Oversight and Government Reform has scheduled a hearing on May 27 to examine the recall.