FDA Issues Tylenol Safety Warning

The Food and Drug Administration is urging parents to choose generic children’s medications over Tylenol as it broadens its investigation into manufacturing facilities operated by Johnson & Johnson and its subsidiary, McNeil Consumer Healthcare.

New product safety concerns have arisen in the weeks after an April 30 recall involving McNeil’s Fort Washington facility in Pennsylvania, prompting the FDA to start investigating other manufacturing sites. McNeil recalled 43 over-the-counter children’s medicines it manufactures for Johnson & Johnson, including various flavors of liquid Tylenol, Motrin, Benadryl and Zyrtec. The FDA has not said how many facilities are being investigated.

McNeil Consumer Healthcare issued the April 30 recall voluntarily in consultation with the FDA. In a visit to McNeil’s Fort Washington facility, FDA officials uncovered inconsistent active ingredient concentrations, extremely potent metal particles in some medicines, an inadequate testing facility, poorly trained employees and drums of raw materials contaminated with bacteria.The full inspection report is available here.

Meanwhile, the House Committee on Oversight and Government Reform is scheduled on Thursday, May 27, 2010 to hold a hearing on the recent Tylenol recalls and whether McNeil properly handled consumer complaints.  In a recent Fortune Magazine interview, Johnson & Johnson Chief Executive William Weldon admitted that his company owed an apology.  Mr. Weldon has been invited to testify at the May 27 hearing.

The Pennsylvania facility has since been shut down but may resume operation once, according to Johnson & Johnson spokesman James Freeman, “we have taken the necessary corrective actions and can assure the quality of products made there”.

Tylenol has been involved in other product safety recalls in recent years. In 2008, McNeil recalled 51 types of Tylenol after consumer complaints of diarrhea, vomiting and other illness. The company said the medications – mostly all for children and infants – had been contaminated by trace amounts of a chemical used in shipping.

In 2008, McNeil recalled 21 types of children’s and infants’ Tylenolbliquid products, saying an active ingredient did not meet all quality standards.

For additional information on the Johnson & Johnson recalls, see the FDA’s website.

For assistance with a case involving injury or illness from consumption of a recalled medication, or other defective product, contact the experienced attorneys at Breakstone, White and Gluck.  The Boston-based lawyers have extensive knowledge of and experience with product liability, and other personal injury and wrongful death cases.  For a free consulation, call 800 379 1244.

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