McNeil Consumer Healthcare, might not be a household name but the over-the-counter infant’s and children’s liquid medicines it manufactures as a subsidiary of Johnson & Johnson certainly are. Children’s Tylenol, Infant’s Tylenol, Children’s Motrin, Children’s Zyrtec and Children’s Benadryl are the medicines of choice for many parents. When the company voluntarily recalled more than 136 million bottles of those medications last month, it’s hardly a wonder that parents were upset.
The massive recall was ordered by the company because the medications might have contained too much of the active ingredient of the drug, metal specks or inactive ingredients that failed testing standards. Johnson & Johnson, McNeil and the Food and Drug Administration, the latter responsible for the safety of medicines sold in this country, say that there is no indication that a child has been harmed by any of the recalled products. That is welcome news. So is the FDA’s announcement that other OTC brand-name and generic pediatric products currently on sale in stores are safe to use.
The investigation of McNeil, however, remains active. It should, There is increasing evidence that the manufacturer of the popular medications apparently engaged in a on-going pattern of violations in manufacturing and quality control practices so egregious that the recalls became necessary. The extent of those problems became apparent at a Congressional hearing held on Thursday.
The recall last month was the third of McNeil products in eight months. Other problems, members of the House Committee on Oversight and Government Reform were told, go back two years. The company’s manner of addressing problems clearly troubled committee members. It should concern consumers as well.
In 2008, the company began to get complaints that a moldy odor was coming from some over-the-counter products manufactured in a plant in Puerto Rico. The company, however, did not notify the FDA of the problem until 2009. Dr. Joshua M. Sharfstein, the FDA’s principal deputy commissioner, told a Johnson & Johnson executive testifying at the hearing Thursday that such delay was unacceptable. “It should not have taken a year,’ he said. “It should have taken three days.”