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12/29/09 - 04:35 PM
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A popular over-the-counter medication that helps millions of people is pulled off the shelves.
The FDA says shipping contamination may be causing adverse side effects.
All Tylenol Arthritis Pain Caplet 100-count bottles with the distinctive red EZ-Open cap are being recalled.
It’s an update to the five lots of that same pill form that were recalled in November.
With coughs, colds, aches and pains this winter, many people turn to medications for relief.
But those looking for relief from arthritis pain may need to switch from their usual relief due to a recall.
McNeil Consumer Healthcare is expanding its voluntary recall of Tylenol Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-Open cap.
In November, 5 lots of the drug were recalled. The FDA says this was due to consumer reports of an “ususual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea.”
The FDA reports that the smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.
Its believed to be the breakdown of a chemical used to treat the wooden pallets that transport and store packing materials.
The FDA says the health effects of the compound have not been well-studied but that the side effects reported were temporary and not serious.
If you have purchased Tylenol Arthritis Pain Caplet 100-count bottles with the EZ-Open cap, stop using the product and contact McNeil for instruction on a refund of replacement.
You can contact McNeil for instructions, both by phone and through email.
For instructions or information regarding how to return or dispose of the product, consumers should call 1- (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).
You can also email the company by clicking here.
Consumers who have medical concerns or questions should contact their healthcare provider.
The FDA says any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20, or on the MedWatch website.
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