Mcneil consumer healthcare recalls four product lots of benadryl® allergy ultratab™ tablets, 100 count, and one product lot of extra strength tylenol® rapid release gels, 50 count

Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl®
Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra
Strength Tylenol® Rapid Release Gels, 50 Count
Contact:
Bonnie Jacobs
215-273-8994
Marc Boston
215-273-7649
FOR IMMEDIATE RELEASE - Fort Washington, PA - June 15, 2010 - McNeil
Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an
addition to the list of products included in the company’s January 15th, 2010 product
recall. The additional lots involved are four product lots of BENADRYL® ALLERGY
ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA
STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and
Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW).
This recall is a follow-up to the product recall that McNeil Consumer Healthcare
announced on January 15th, 2010 and is being taken because the products were
inadvertently omitted from the initial recall action. McNeil Consumer Healthcare
identified the omission and informed the U.S. Food and Drug Administration (FDA) of
its decision to add these product lots to the recall list. All these products were produced
before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has
continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that
information with the FDA. This further analysis confirms that the risk of serious adverse
medical events is remote. This recall is being conducted with the knowledge of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu. The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials. Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at or call 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). Requests for reimbursement can be made atonsumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http:www.fda.gov/safety/medwatch/default.htm. The product lot numbers for the recalled products can be found on the side of the bottle label. FULL RECALLED PRODUCT LIST:
Product Name
Lot Number

Source: http://www.lynnisd.com/Temp%20info/6-22-10-Benadryl,Tylenol%20exp%20recall.pdf