Recalls

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January 15, 2010 — Because of a sickening smell in some containers,

54 million packages of 27 different over-the-counter remedies now are

being recalled.

Products include various types of child and/or adult Tylenol,

Motrin, Benadryl, St. ph Aspirin, Rolaids, and Simply Sleep. This

adds to the 6 million packages of Tylenol recalled late last year,

bringing the total number of recalled products to 60 million.

A musty, moldy odor coming from the products has sickened at least

70 people with nausea, stomach pain, vomiting, and diarrhea. The

symptoms go away by themselves and no one has been seriously injured.

The FDA says & 's McNeil Consumer Health Care

knew of the problem for more than a year. When the company did act in

November and December 2008, it did too little too late, said Deborah M.

Autor, director of the FDA's Office of Compliance.

" When something smells bad, literally or figuratively, companies

must aggressively investigate and take all actions necessary to solve

the problem, " Autor said at a news conference. " McNeil should have

acted faster. "

The odor comes from a chemical, 2,4,6-tribromoanisole or TBA. TBA is

produced when fungi break down a commonly used fungicide called

2,4,6-tribromophenol. The full health effects of TBA are not known.

Before being filled with product, product containers were stored on

wooden pallets apparently treated with the fungicide. TBA seems to have

infiltrated the product containers before they were filled.

The FDA inspected McNeil's main plant at Las Piedras, Puerto Rico,

and was not happy with what it found. The FDA says McNeil began

receiving complaints in May 2008, but failed to investigate fully or to

warn consumers in a timely manner.

The FDA has given McNeil 15 days to respond to its seven-point

warning letter. In addition to the contamination issue, the FDA says

there are product-quality issues with some Motrin products.

Specific products included in the recall include:

Children's MotrinChildren's TylenolExtra Strength TylenolRegular Strength

TylenolTylenol 8 HourTylenol ArthritisTylenol PMBenadrylMotrin IBRolaidsSimply

SleepSt. ph Aspirin

A complete list of the recalled products, including package sizes,

product types, lot numbers, and UPC codes, can be seen at

www.mcneilproductrecall.com. Consumers with question can call McNeil at

.

Consumers who think they may have suffered ill effects from the products should

contact the FDA at www.FDA.gov/medwatch.

SOURCES:

FDA news conference with Deborah M. Autor, director,

Office of Compliance (OC), Center for Drug Evaluation and Research

(CDER), FDA; Woo, MD, associate director for medical and

scientific affairs, OC, CDER, FDA, and Hirshfield, acting branch

chief, Recalls and Shortages Branch, OC, CDER, FDA.

PR Newswire, Jan. 15, 2009

News release, J & J McNeil Consumer Healthcare.

FDA warning letter to McNeil, Jan. 8, 2009.