McNeil spokeswoman Bonnie Jacobs said it was too soon to say when the product will return to the market. The company said customers can continue to use the infant Tylenol if the bottle's flow restrictor remains intact. The company's prescription drug and medicial device divisions each have issued at least two recalls in the last couple years.
Reasons for the recalls have included nauseating package odors, small glass or metal particles in liquid medicines and wrong levels of active ingredients. Please enter email address to continue.
Joshua Sharfstein, principal deputy commissioner at the FDA, told the House Committee on Oversight and Government Reform , the agency was "considering additional enforcement actions against the company which may include seizure, injunction and criminal penalties. Sharfstein said, "Although the public health risks from these quality problems is low, these problems should never have occurred.
And the manufacturing failures at the facility that caused them were unacceptable. But Goggins defended the company's handling of the recall and denied it ever knowingly used any contaminated products. She said McNeil has "made significant organizational changes," hiring new officials to oversee quality and plant operations.
Committee chairman Rep. Edolphus Towns, D-New York, said, "There is nothing this committee will investigate that is more serious than the health of our children. We will use all of our authority to find out what went wrong and do everything that we can to ensure that it does not happen again. Towns wanted an assurance no one could give him. But he added that no injuries or deaths have been attributed to any of the recalled medicines.
One member of the committee said McNeil was guilty of a "culture of mediocrity. A full list of the over 40 affected products made by McNeil Consumer Healthcare is available at www.
McNeil said it was recalling the products in consultation with the FDA after discovering manufacturing deficiencies that could affect the quality, purity or potency of the medicines. The FDA said some of the products may not meet required quality standards, and parents and caregivers should stop administering them to children and switch to generic brands, which are not affected by the recall.
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