Johnson & Johnson's McNeil Consumer unit woes escalate, with FDA eyeing civil or criminal charges

What started off earlier this year as seemingly a minor product recall of over-the-counter medicines at USA-based McNeil Consumer Healthcare could become a major problem from its parent company, health care giant Johnson & Johnson.

At a House Committee on Oversight and Government Reform hearing on the recall relating to McNeil's Fort Washington, Pennsylvania, production plant, Food and Drug Administration Deputy Commissioner Joshua Sharfstein told the committee that the FDA had 'growing concerns about the quality of the company's manufacturing process' before the spring recall, according to a Reuters report. He said regulators were considering such punitive measures as "seizure, injunction or criminal penalties." The FDA's criminal investigations office is looking into the matter, an aide said.

McNeil on April 30 announced a voluntarily recall of products, mainly for use by children, including a variety of liquid formulations of Tylenol, Motrin, Benadryl and Zyrtec. The recall followed an inspection of the Fort Washington plant, which temporarily suspended production May 4, by the FDA. That inspection, according to the agency, identified a series of quality control issues including the discovery of raw materials contaminated with bacteria in some of the recalled medicines. McNeil had two other product recalls in 2009.