FDA Announces Widespread Investigation Of McNeil After Tylenol Recalls

Remember the recalled liquid Tylenol and other children’s medicines last month? Or the stinky drugs that were recalled back in January? Or the children’s Tylenol that was recalled last September? The FDA remembers, which is probably why it’s “conducting a company-wide investigation of McNeil Consumer Healthcare’s drug manufacturing practices to determine whether similar problems exist throughout the company.” Also, a date has now been set (May 27) for the House Committee hearing where the CEO and chairman of parent company Johnson & Johnson are expected to testify.

This is one case where the company has been asking for trouble (meaning government intervention) for a while now–all three recalls in the past nine months have been related to quality control issues at production facilities. ABC News said the FDA met with representatives of McNeil and Johnson & Johnson back in February to “express its concerns about their production practices.” The company reps promised they were taking care of the problem, but two months later McNeil announced its recall of children’s drugs that were potentially contaminated, and a subsequent plant inspection revealed a dirty facility with poor quality-control.

“FDA ‘actively pursuing’ McNeil Consumer Healthcare” [Drugs Store News]
FDA Media Update re. McNeil Invesgiation (PDF) [FDA]