Children's Tylenol recall: FDA slams factory conditions
By Parija Kavilanz, senior writerMay 4, 2010: 4:59 PM ET
NEW YORK (CNNMoney.com) -- A scathing report released Tuesday by the Food and Drug Administration slammed conditions at the factory that produced the children's Tylenol, Motrin and other over-the-counter drugs that were recalled over the weekend.
The 17-page FDA report provided a detailed description of quality and security lapses at the Fort Washington, PA-based facility, which is owned by Johnson & Johnson's (JNJ, Fortune 500) McNeil PPC drug manufacturing division.
The FDA said that the company did not initiate "corrective and prevention action" after it had received 46 consumer complaints from June 2009 to April 2010 regarding foreign materials and black or dark specks in its drugs.
The agency cited the facility for not following quality controls and for not maintaining adequate lab facilities for the testing and approval of components and drug products.more...
http://money.cnn.com/2010/05/04/news/companies/tylenol_recall_fda_inspection_report/