The 17-page report follows a national recall issued this past weekend by Johnson & Johnson and its subsidiary McNeil PPC, which owns the plant, of the above mentioned medicines. It states that McNeil failed to take "corrective and prevention action" even after it had received some 46 consumer complaints between June 2009 and April 2010, CNN.com reports. The complaints related to the presence of foreign materials such as black or dark specks in the medications.
Deborah Autor, the FDA's director with the Office of Compliance, told CNN.com that this is the fourth recall issued by McNeil in the past seven months. "This is yet another example of when a company has to take full accountability for the quality of its drugs [with] severe consequences for not doing so," she said.