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Congressional hearing expected to examine practices at Tylenol plant

By the CNN Wire Staff
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Tylenol maker's side effects woes
STORY HIGHLIGHTS
  • Drug company has recalled products 4 times in 7 months
  • Recalls include children's version of Tylenol and Motrin
  • Johnson and Johnson shut down plant, outlines steps to remedy lapses
  • For more information on recalled products, go to the McNeill recall site

Washington (CNN) -- Lawmakers have scheduled a hearing Thursday to look into the recall of popular pediatric medicines by drugmaker McNeil Consumer Healthcare, which has initiated four recalls of its products in the past seven months.

Among those testifying will be Colleen Goggins, the worldwide chairman of Johnson and Johnson, of which McNeil is a division.

The House Committee on Oversight and Government Reform also invited Johnson and Johnson Chief Executive William Weldon, but he declined to attend because of health reasons.

A panel of Food and Drug Administration officials will also be at the hearing.

The recalls include popular over-the-counter drugs such as Tylenol, Motrin and Benadryl.

More information on recalled products

Fifty children's versions of these nonprescription medicines were also recalled on May 1 because of quality and safety concerns.

McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.

Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product, according to the FDA.

Adverse events could include death, hospitalization, disability and other health complications.

Following the pediatric medicine recall, Johnson and Johnson suspended production at McNeil's facility in Fort Washington, Pennsylvania that manufactured the children's drugs.

On Tuesday, the drugmaker outlined steps to remedy serious quality and safety lapses at the Fort Washington plant and its other manufacturing facilities.

"McNeil is taking steps to bring its operation back to a level of quality that Johnson and Johnson demands of its companies, and that the public rightly expects of us, and that we expect of ourselves," the company said in a statement.

Among the measures, the drugmaker said it has hired an independent pharmaceutical consulting firm to identify corrective actions to improve quality and manufacturing systems at its Fort Washington facility.

McNeil did not say when it would resume production at the plant.

Regarding its products, McNeil said it will conduct in-depth quality assessments for each product that the company manufactures to "ensure each product's ability to meet specifications throughout its shelf life."

The company also said it will update the FDA about its progress implementing the plan at least once a month and would involve an independent firm in making product decisions during the first six months of operation.

McNeil's other recalls in the past seven months were:

-- In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.

-- In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.

-- In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.

 
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