McNeil, the maker of Tylenol and a division of Johnson & Johnson, has come under fire due to a slew of recent recalls. The company “has recalled products four times in the past seven months,” according to a report by CNNMoney.com, "including “a widespread recall of children’s non-prescription drugs on April 30.”
FDA documents show that even though drug manufacturer was aware of a problem with Motrin in November 2008, it did not issue a recall until July 2009. McNeil instructed contract employees to buy up large quantities of Motrin for “testing” and not to mention a recall.
The fact that a company that is so well-known and reputable would engage in such practices is disturbing, especially when the product is so common and involves pediatric over-the-counter drugs. This sentiment is echoed by the House Committee on Oversight and Government Reform.
McNeil received a warning letter from the FDA in January "expressing serious concerns about the company’s control over the quality of its drugs and the company’s failure to aggressively investigate and correct quality problems." In February, Johnson & Johnson was put on notice for concern over quality control and product safety. Concerns include a possible bacterial contamination, small metal particles, and high concentrations of acetaminophen.
Now, Tylenol has been referred to the FDA’s crime division, indicating that there are potential criminal penalties. The company has halted production at the plant that manufactured the children’s drugs in Pennsylvania. This week, “Johnson & Johnson outlined steps to remedy the quality and safety lapses at its manufacturing facilities.” Hopefully the company that has been trusted for so long will be able to stick to their plan. In the meantime, the FDA will continue to investigate cases of death that may potentially be linked to the sloppy manufacturing.