Tylenol Manufacturer May Face Criminal Charges

A congressional hearing has begun looking into the events surrounding the massive children’s Tylenol recalls that have occurred in the last seven months. The hearing comes after the 4th recall issued by the McNeil Consumer Healthcare plant. The latest recall included 136 million bottles of liquid Tylenol, Benadryl, Motrin and Zyrtec medicines. McNeil manufactures liquid Tylenol products and is a subdivision of Johnson & Johnson.

The FDA is sticking to their story that the chances of a person being harmed by the recalled products is or was “remote.” However, the FDA is investigating more than 700 claims of serious side effects involving the medicines recalled. At least 30 deaths have been reported as well, but no definitive link has been established between the over-the-counter medicines and the incidents.

McNeil has been on the FDA radar for quite some time. They have received numerous citations and are now being accused of secretly completing a voluntary recall without notifying the FDA. The FDA claims the company hired a private contractor in 2008 to remove packages of Motrin that were suspected of having quality issues.

The FDA has not ruled out extreme enforcement actions that may include seizures, injunctions and possibly criminal charges. The FDA has stated the case has been turned over to the crime division for further investigation and evaluation. Actions by the FDA are also being investigated. The House Committee on Oversight and Government Reform will determine if the FDA took appropriate action in regard to the numerous violations cited by its own investigators.