FORT WASHINGTON, Pennsylvania – Johnson and Johnson has voluntarily recalled nearly 61,000 bottles of Tylenol Extra Strength Caplets due to complaints of a musty, moldy odor. The recall was issued on June 28 after a “small number of odor reports,” said McNeil Consumer Healthcare, a unit of Johnson and Johnson.
Company officials said the recall involves 225 count bottles and the product was manufactured in February 2009.
This is the second recall Tylenol has had this this year due to complaints of a musty, moldy odor with the first recall occurring in March 2011. That recall affected Tylenol 8-Hour Extended Release Caplets 150 count bottles.
McNeil said the cause of the uncharacteristic odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).
This voluntary action is being taken as a precaution and the risk of serious adverse medical events is remote. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.
The recall is for: Tylenol, Extra Strength Caplets, 225 count, with the Lot Number ABA619 and the UPC Code 300450444271.
The product lot number for the recalled product can be found on the side of the bottle label.
Consumers who purchased product from the lot included in this recall should stop using the product 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) for instructions about receiving a refund or product coupon.
Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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