McNeil recalls more OTC drugs.
McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary GI symptoms.
In a press briefing to announce the expanded recall, FDA officials called McNeil to task for acting too slowly.
The voluntary recall affects certain lots of Benadryl, Tylenol, Motrin IB, Rolaids, Simply Sleep, and St. Joseph Aspirin. A full list of the affected products and their lot numbers can be found at www.mcneilproductrecall.com.
The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.
This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count in December 2009.
The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.
After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tri-bromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.
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|Title Annotation:||NEWS FROM THE FDA; over the counter drugs|
|Publication:||Internal Medicine News|
|Article Type:||Brief article|
|Date:||Feb 15, 2010|
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