Image: Tylenol
Paul Sakuma  /  AP
Johnson & Johnson on Thursday announced that it is expanding a recall of over-the-counter drugs including Tylenol and Motrin IB because of a musty or moldy smell.
updated 7/8/2010 7:03:40 PM ET 2010-07-08T23:03:40

Johnson & Johnson said Thursday it is expanding a recall of over-the-counter drugs including Tylenol and Motrin IB because of a musty or moldy smell.

The McNeil Consumer Healthcare business said it is recalling 21 lots of over-the-counter drugs sold in the U.S., Puerto Rico, Fiji, Guatemala, the Dominican Republic, Trinidad and Tobago, and Jamaica. The drugs that are being recalled include Benadryl, Children's Tylenol, Motrin IB, Tylenol Extra Strength, Tylenol Day & Night, and Tylenol PM.

The New Brunswick, N.J., company had already made a large recall of those drugs and over-the-counter products on Jan. 15, saying about 70 people noticed the smell. Some of them got sick, with symptoms including nausea, stomach pain, vomiting and diarrhea. The odor was linked to a chemical in shipping pallets and traced to a facility in Puerto Rico.

The company said the new lots were added to the recall as a precaution after an internal review found those lots, shipped and stored before Jan. 15, had been on the same type of wooden pallets.

The world's biggest maker of health care products, Johnson & Johnson enjoyed a strong reputation for safety, but it has dealt with several product recalls since late last year. It withdrew over-the-counter drugs in November and December 2009 before issuing a much larger recall in January. Federal regulators said McNeil was told about the problem in early 2008 but made a limited investigation and did not tell the Food and Drug Administration quickly.

The original withdrawal also included other types of Tylenol, Benadryl, Rolaids, Simply Sleep, and St. Joseph's aspirin.

In late April, McNeil recalled more than 130 million bottles of children's medicines like Tylenol, Benadryl, and Motrin because of manufacturing problems at a plant in Fort Washington, Pa. Some of the drugs had the wrong ingredient levels, and others contained tiny particles of metal.

KathyJo Andrews threw out 10 bottles of children's medicines earlier this summer after a prior recall.

"It scared me," she said. "It's my kids."

Since then the mother of two, who lives in the Chicago suburb of Oak Lawn, has received coupons from Johnson & Johnson to reimburse her, but doesn't plan to use them soon.

Andrews said when her 6-year-old developed a fever and had an allergic reaction, she opted instead to take a trip to the pediatrician.

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"I'd much rather pay for a doctor's visit and a prescription from the pharmacy than have to freak out and worry about it," the 28-year-old said.

A Johnson & Johnson spokeswoman said the company had no comment beyond its announcement of the latest recall.

Food and Drug Administration spokeswoman Elaine Gansz Bobo said the agency continues to work with McNeil on all the product recalls.

"We do not see any serious health risk to the public from this additional recall," she said.

Gansz Bobo said she did not know of any other company that had eight medicine recalls in less than a year.

"It certainly is quite a few, and something that we hope is not repeated by other companies," she told The Associated Press.

The repeated recalls are particularly surprising at a company where executives regularly repeat the 67-year-old corporate credo, which begins: "We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services."

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Video: FDA: Johnson & Johnson mishandled recalls

  1. Transcript of: FDA: Johnson & Johnson mishandled recalls

    BRIAN WILLIAMS, anchor: We're back now with news that one of America 's most trusted brand names, it's in virtually every American home , is in full damage control mode tonight. Just a month after recalling more than 40 types of children's Tylenol and other popular medicines, Johnson Johnson is now accused of taking steps to avoid a recall of an adult medicine. Our report on this tonight from NBC 's Tom Costello .

    TOM COSTELLO reporting: Still reeling after recalling more than 50 million bottles of children's medicines, Johnson Johnson , one of the most trusted consumer names in America , today admitted that it let its customers down.

    Ms. COLLEEN GOGGINS (Johnson Johnson Consumer Group Worldwide Chairman): On behalf of McNeil and Johnson Johnson , I apologize to the mothers, the fathers and the caregivers for the concern and inconvenienced caused by the recall.

    COSTELLO: But the company is facing new allegations that it knew of some potential problems with its adult Motrin tablets as early as 2008 . Representative EDOLPHUS TOWNS (Democrat, House Oversight and Government Reform Committee Chair): But rather than issue a recall, McNeil allegedly sent contractors out to the stores to buy the products back and told the stores not to mention a recall.

    COSTELLO: Johnson Johnson says it was all a misunderstanding.

    Ms. GOGGINS: There was never any intent to mislead or hide anything from anyone.

    COSTELLO: And Johnson Johnson denied it ever sold any products contaminated with bacteria. But last month's recall of children's Tylenol , Motrin , Zyrtec and Benadryl have concerned parents, like Heather Skripsak , near Detroit , whose two-year-old daughter Allison was given Tylenol after having her tonsils removed.

    Ms. HEATHER SKRIPSAK: Your doctor is telling you to give her this and you think that she's in pain, and obviously at that point she needs something.

    COSTELLO: Allison suffered no side effects, and the FDA says it has no evidence that any child suffered any injuries or died after ingesting the recalled medicines. Still, an FDA watchdog says Johnson Johnson 's golden reputation has been tarnished.

    Dr. SIDNEY WOLFE (Public Citizen): This is not just one instance. It's a series of instances involving multiple products, multiple defects in the plant.

    COSTELLO: Today the FDA 's deputy commissioner agreed.

    Dr. JOSHUA SHARFSTEIN (FDA Deputy Commissioner): This is a company that had a major problem with compliance.

    COSTELLO: Johnson Johnson insists it's taken dramatic steps to clean up the plants where the recalled products were made. Meanwhile, the FDA says it's referred the matter to its criminal division for consideration. Tom Costello, NBC News, Washington.

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