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Various McNeil Consumer Healthcare products |
| Tylenol, Benadryl, Motrin, Simply Sleep, and St. Joseph products |
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Pharmaceutical
company:
McNeil Consumer Healthcare www.mcneilproductrecall.com |
NEW WARNING
The Food and Drug Administration and McNeil Consumer Healthcare notified health care professionals of the expansion of the December 2009 recall of acetaminophen (Tylenol Arthritis Pain Caplet). The initial recall was issued after consumers reported an unusual moldy, musty, or mildew-like odor that was associated with nausea, vomiting, and diarrhea. The odor was linked to the chemical 2,4,6-tribromoanisole thought to be the breakdown of a chemical used to treat wooden pallets used to transport and store packaging materials.
McNeil Consumer Healthcare is now removing all product lots at risk for being affected, even if they have not been included in the consumer complaints. Consumers who purchased products from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement.
The affected product names and lot numbers for the recalled products can be found here. It includes a wide variety of products sold under the brand names Benadryl, Motrin, Simply Sleep, Tylenol, and St. Joseph.
Any adverse reactions may also be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program online, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
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