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Drug Recall Probe Goes Nationwide

The Food and Drug Administration, or FDA, said Monday it is expanding nationwide its investigation of a Johnson & Johnson unit linked to the recall of some 50 children’s versions of Tylenol, Motrin, Benadryl and other defective drugs.

On May 6, five days after the recall, the FDA issued a report identifying 20 violations at the unit’s Pennsylvania plant that produced the drugs. According to one violation, the division, McNeil Consumer Healthcare, had received 46 consumer complaints on the recalled products but had taken no action. The FDA urged all parents to stop using the recalled products and to use generics instead.

Now the agency will investigate McNeil’s manufacturing practices across the country “to determine whether similar problems exist throughout the company,” according to a statement posted on the FDA Website Monday. The statement did not say how many facilities will be targeted in the expanded probe.

In announcing the May 1 recall, McNeil said some of the products may have contained an incorrect ingredient concentration, ingredients that failed to meet testing requirements, or tiny metal particles.

The House Committee on Oversight and Government Reform has scheduled a May 27 hearing on the recall. William Weldon, chief executive of Johnson & Johnson, has been invited to testify.

If the expanded probe uncovers new problems with the company’s drug manufacturing process, the health of more children could be at risk. At Schlichter, Bogard & Denton, we have the resources and the expertise to litigate in all circumstances. If you fear that you or a family member has suffered injury from defective drugs, contact us for a free consultation at any of our nationwide offices.

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