RIMS | Risk Management Magazine
In May, Johnson & Johnson announced a voluntary recall of more than 40 varieties of children's and infants cold medicines after an FDA inspection at a McNeil manufacturing plant in Fort Washington, Pennsylvania found 20 different violations, including raw materials contaminated with bacteria, equipment covered in thick dust, repairs made with duct tape, holes in the ceiling, and poor safety and quality controls.
This is the third recall of Tylenol products in less than a year. In January, Tylenol recalled 50 products when customers began to complain about moldy-smelling bottles and nausea, stomach pain, vomiting and diarrhea after using the medications. The cause was traced to contamination from a chemical used in packaging. Before that, in September 2009, McNeil recalled 21 Tylenol products because of possible bacterial contamination of an inactive ingredient.
This string of recent quality issues has caught the attention of lawmakers, who have decided to open an investigation into McNeil's safety practices.
