Johnson & Johnson shutters Pennsylvania plant, recalls Children’s Tylenol and 40 other products
Reuters reports that U.S. inspectors found thick dust and contaminated ingredients at the plant in Pennsylvania that produces Children’s Tylenol and about 40 other products that were recalled last week.
A Food and Drug Administration report said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at Johnson & Johnson’s Fort Washington, Pennsylvania, facility.
Inspectors also found raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints, according to the report dated April 30.
The findings were a further blow to J&J’s reputation, as the FDA later on Tuesday urged parents to choose private label alternatives for the over-the-counter medications and said it was weighing possible further regulatory action.
“Consumers should not use these products,” Deborah Autor, director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research told reporters in a conference call, even though the chance of getting sick from the recalled products was “remote.”
There were 46 consumer complaints about dark material in the liquid products between June 2009 and April 2010, according to the FDA report.
J&J, which has issued four major product recalls in the last year, said on Tuesday that the quality problems at the plant “are unacceptable to us” and that it would continue to work closely with the FDA to fix them.
The company has suspended production at the plant.
“We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there,” said a statement from J&J’s McNeil Consumer Healthcare unit.
On Saturday, the FDA urged consumers to stop using liquid Tylenol, Motrin, Benadryl and Zyrtec for children and infants after a broad recall late on Friday.
A full list of more than 40 affected products made by McNeil Consumer Healthcare can be found at www.mcneilproductrecall.com.
– Source: Reuters