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
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 www.mcneilproductrecall.com 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
at www.mcneilproductrecall.com.
Consumers 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
|
Product Form
|
Lot Number
|
NDC Number
|
UPC Code
|
|
BENADRYL Allergy ULTRATAB Tablets 100 count
|
Ultratab
Tablet
|
AJA008,
ADA194, ABA022, ABA264
|
50580-226-10
|
312547170338
|
|
EXTRA
STRENGTH Tylenol Rapid Release
Gels 50 count
|
Rapid
Release Gelcap
|
ASA202
|
50580-488-50
|
300450488503
|