Another Recall From McNeil Consumer Healthcare

McNeil Consumer Healthcare 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. 

Follow-up

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. The company 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 then, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has sent that information to FDA.  The company stresses that this further analysis confirms the risk of serious adverse medical problems is remote.

Products involved

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.

Consumer actions

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 can go online 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).  Those 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, MD20852-9787 or online. 

The product lot numbers for the recalled products can be found on the side of the bottle label.

FULL RECALLED PRODUCT LIST: