Expanded Recall Of & Products

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On Friday January 15, 2010, 10:10 am

NEW YORK (AP) -- & expanded a recall of over-the-counter

medications Friday, the second time it has done so in less than a month because

of a moldy smell that has made users sick.

The broadening recall now includes some batches of Tylenol caplets, geltabs,

arthritis treatments, rapid release, and extended relief Tylenol, as well as

Motrin IB, regular and extra strength Rolaids antacids, Benadryl allergy

tablets, St. ph aspirin, and Simply Sleep caplets.

Almost three weeks ago, the company's McNeil Consumer Healthcare Products

expanded its recall to include Tylenol Arthritis Caplets.

McNeil said the larger recall includes product lots that could be affected by

the same problems of nausea even though it has not received any reports from

consumers. A full list of the recalled products is online at

http://www.mcneilproductrecall.com.

The latest recall applies to products sold in the Americas, the United Arab

Emirates, and Fiji.

& recalled some Tylenol Arthritis Caplets in November and

December due to the smell, which caused nausea, stomach pain, vomiting and

diarrhea.

& says the smell is caused by small amounts of a chemical

associated with the treatment of wooden pallets.

The New Brunswick, N.J., company said it is investigating the issue and will

stop shipping products with the same materials on wooden pallets. It has asked

suppliers to do so as well.

The company said it is working with the Food and Drug Administration.

 

CONSUMER INQUIRIES:

1-888-222-6036 (Mon-Fri 8 a.m. to 10 p.m. EST, and Sat-Sun 9 a.m. to 5 p.m. EST)

MCNEIL CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF CERTAIN

OVER-THE-COUNTER (OTC) PRODUCTS IN THE AMERICAS, UAE, AND FIJI

Fort Washington, PA (January 15, 2010) In consultation with the U.S. Food and

Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC,

Inc., is voluntarily recalling certain lots of OTC products in the Americas, the

United Arab Emirates (UAE), and Fiji (FULL RECALLED PRODUCT LIST BELOW). The

company is initiating this recall following an investigation of consumer reports

of an unusual moldy, musty, or mildew-like odor that, in a small number of

cases, was associated with temporary and non-serious gastrointestinal events.

These include nausea, stomach pain, vomiting, or diarrhea. This precautionary

action is voluntary and has been taken in consultation with the FDA.

Based on this investigation, McNeil Consumer Healthcare has determined that the

reported uncharacteristic smell is caused by the presence of trace amounts of a

chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown

of a chemical that is sometimes applied to wood that is used to build wood

pallets that transport and store product packaging materials.. The health

effects of this chemical have not been well studied but no serious events have

been documented in the medical literature. A small number of the product lots

being recalled were associated with the complaints of an unusual moldy, musty,

or mildew-like odor, and some of these lots were found to contain trace amounts

of TBA. In December 2009, McNeil Consumer Healthcare also recalled all lots of

TYLENOL® Arthritis Pain 100 count with EZ-OPEN CAP related to this issue.

McNeil Consumer Healthcare has now applied broader criteria to identify and

remove all product lots that it

believes may have the potential to be affected, even if they have not been the

subject of consumer complaints.

In addition to the product recall, McNeil Consumer Healthcare is continuing

their investigation into this issue and is taking further actions that include

ceasing shipment of products produced using materials shipped on these wood

pallets and requiring suppliers who ship materials to our plants to discontinue

the use of these pallets. We will continue to closely monitor and evaluate the

situation and consult with the FDA.

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 10

p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). 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, FDA, 5600 Fishers Lane, Rockville,

MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The affected product lot numbers for the recalled products can be found on the

side of the bottle label.

McNeil Consumer Healthcare Division of McNeil-PPC, Inc. markets a broad range of

well-known and trusted over-the-counter (OTC) products.

CLICK HERE FOR RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF Tylenol® Products

CLICK HERE FOR RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF Mortin® Products

CLICK HERE FOR RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF BENADRYL® ALLERGY

ULTRATABâ„¢

CLICK HERE FOR RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF Rolaids® Antacid

Tablets

CLICK HERE FOR RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF Simply Sleep®

Products

CLICK HERE FOR RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF ST. JOSEPH®

Products

 

http://www.mcneilproductrecall.com/page.jhtml?id=/include/press.inc