Johnson & Johnson has announced yet another Tylenol recall, and once again, a foul odor is the culprit.
McNeil Consumer Healthcare, a division of Johnson & Johnson, announced the recall on Monday of a single lot of Tylenol 8-Hour caplet, 50-count bottles it says were sold in the U. S. and Puerto Rico.
The recalled lot number, which can be found on the side of the bottle, is: BCM155. The UPC code is: 3 0045-0297-51 8.
"McNeil is taking this action following a small number of complaints of a musty or moldy odor," the company said in a statement. "The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole."
Tribromoanisole, commonly known as TBA, results from the breakdown of Tribromophenol, a fungicide used to treat wooden pallets used in transporting and storing packaged materials, such as drugs.
TBA, which produces a musty, mildew-like odor, was responsible for the multiple recalls of Tylenol and other Johnson & Johnson drugs in December 2009, and January, June, and July of this year. The initial Tylenol recalls were prompted by reports of consumers suffering from nausea, stomach pain, vomiting and diarrhea.
McNeil said the voluntary recall is a purely precautionary measure, and says any health risk is "remote." To date, the company added, any health problems related to the recalled Tylenol were "temporary and non-serious."
Consumers who bought the tainted Tylenol should stop using it immediately and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their health-care provider.
Any health problems related to the recalled Tylenol should be reported to the FDA's MedWatch Adverse Event Reporting program, either online, via a postage-paid, pre-addressed form letter available here, or via this fax number: 1-800-FDA-0178
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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