McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, is under public scrutiny after pleading guilty in criminal court Tuesday of selling tainted infant Tylenol and Motrin. Reports alleged that McNeil Consumer Healthcare continued to sell product after the company was made aware that the infant Tylenol and Motrin was tainted with metal particles including chromium, iron, and nickle. In addition, an earlier report stated that the Tylenol and Motrin might have been in inconsistent quantities in the liquid drops, according to an RT report.
The metals were reportedly introduced during the manufacturing process at McNeil Consumer Healthcare’s plant in Fort Washington, Pennsylvania. McNeil was first made aware of possible contamination in May 2009, after a consumer complained that there was black specks inside a bottle of purchased Infants’ Tylenol, court documents assert. After checking the problem, McNeil quality control did find metal particles during production. After finding metal particles in the medication meant for infants and children, McNeil continued to manufacture and sell the liquid medication that are often used for teething, fever, aches and pains and after vaccination on infants and children.
McNeil began a voluntary recall in April 2010. On May 1, 2010, a notice was made to the public by the FDA of what they called a “voluntary recall.” The recall information didn’t specify the exact findings, but instead stated that the drugs didn’t meet quality standards and that the recall was introduced as a precaution. According to that recall notice, the products made for infants and children included some Tylenol, Motrin, Zyrtec, and Benadryl products.
“McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use.”
At that time, the FDA Commissioner Dr. Margaret A. Hamburg stated that the potential for serious health problems as a result of the tainted medications were “remote” and that the recall was issued, because “Americans deserve medications that are safe, effective and of the highest quality.”
McNeil acknowledged Tuesday by pleading guilty in accordance with a plea deal to the federal criminal charge that it sold the over-the-counter infant’s and children’s without taking corrective action after the discovery that the Tylenol and Motrin had been tainted. The plea deal resulted in the company agreeing to pay 25 million dollars and pleading guilty in order to resolve the case.
“McNeil’s failure to comply with current good manufacturing practices is seriously troubling,” the acting Assistant Attorney General Mizer said in a statement. “The Department of Justice will continue to be aggressive in pursuing and punishing companies such as McNeil that disregard a process designed to assure quality medicines, especially OTC drugs for infants and children.”
Though the FDA said that the possibility of health concerns due to the contamination of the Tylenol and Motrin that was produced from the Fort Washington McNeil plant was “remote,” the public is now questioning a previous death that had been alleged to have been due to taking only one dose of infant’s Tylenol. In 2012, Shawn Arndt sued the company claiming that Arndt’s son Joshua died at 4-years-old after taking Tylenol. Mr. Arndt alleged that after taking the Tylenol, his son began bleeding from the nose and later died. According to court documents, the bottle of Tylenol that was used in the dose given to Joshua was included in the recall. Johnson & Johnson asked for the case to be dismissed, because Mr. Arndt’s suit wasn’t filed within the two-year statute of limitations period. The US District Court for Eastern Pennsylvania dismissed Arndt’s suit in part against the company (which had since closed that McNeil plant) in December 2014.
According to FDA documentation, when the recall was initiated, McNeil also made “solid oral dosage forms at that facility,” and that McNeil shut down the production of those adult versions as well. However, that report stated that at that time, there was no indication that a recall on the adult versions of the drugs was warranted. Additional detailed information into McNeil’s inspections is available for public viewing on the FDA’s website. The FDA investigation, according to RT, traced the Tylenol and Motrin contamination to machinery in the McNeil plant which came from violations in manufacturing and also from “airborne contamination from a chemical used for wood pallets.”