FDA expands investigation into drug manufacturer
The Food and Drug Administration (FDA) is expanding its investigation of a manufacturing arm of Johnson & Johnson following the recent recall of several popular over-the-counter children’s drugs.
Earlier this month, McNeil Consumer Healthcare recalled approximately 50 children’s drugs, including Benadryl, Tylenol, and Motrin. Some of the products may contain incorrect concentrations of ingredients and tiny metal particles; some also failed testing requirements. Soon after the recall, the FDA issued a 17-page report listing 20 violations of federal regulations at McNeil’s Fort Washington, Pennsylvania plant where the recalled products were made. Johnson & Johnson has since closed the facility. The company has not to date disclosed all of the products that were manufactured at the plant.
According to the FDA report, McNeil failed to take any action even after receiving 46 complaints about the products in question. And earlier this year, a McNeil facility in Puerto Rico was the subject of a recall involving adult versions of non-prescription drugs after complaints of a musty-smelling odor from products manufactured at the plant.
The FDA is now conducting a company-wide investigation into whether similar problems exist at other McNeil facilities. Additionally, the House Committee on Oversight and Government Reform is holding a hearing later this month about the recall.
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