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.
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.
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
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
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
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
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:
|Product Name||Product Form||Lot Number||NDC Number||UPC Code|
|BENADRYL ALLERGY ULTRATAB TABLETS||100
count UltratabTablet||AJA008, ADA194, ABA022, ABA264||50580-226-10||312547170338|
|EXTRA STRENGTH TYLENOL||Rapid Release Gels 50
countRapid Release Gelcap||ASA202||50580-488-50||300450488503|
Another Recall From McNeil Consumer HealthcareProducts include some lots of BENADRYLÂ® ALLERGY ULTRATABâ„¢ TABLETS and EXTRA STRENGTH TYLENOL ...