Late last year, McNeil Consumer Healthcare announced a recall of all Tylenol Arthritis Pain Caplet 100 count bottles, with the red EZ-open cap. The recall was prompted by consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting, and diarrhea. The odor was traced to minute amounts of a chemical called 2,4,6-tribromoanisole (TBA), which can result from the breakdown of a chemical used to treat wooden pallets.
This past month, the recall was expanded to additional over-the-counter products, including Children’s Motrin and Tylenol, Benadryl, extra and regular strength Tylenol, Tylenol Arthritis, Rolaids, Simple Sleep caplets, and St. Joseph’s Aspirin.
McNeil has set up a website to provide further information to consumers about the recall.
On January 15, 2010, the FDA issued a "warning letter" to McNeil concerning violations discovered during an inspection of its pharmaceutical manufacturing facility in Puerto Rico.
Based on the complaints made to McNeil concerning the odors and the company's follow up measures, the FDA letter also harshly criticized the company's investigation into the root cause of the odor and subsequent responses. Read the full "warning" letter here.
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