BusinessWeek (May 4, 2010)
"Agency also cited maker Johnson & Johnson for 'numerous deficiencies' at plant"
"Bacterial contamination has been found in ingredients used to make the liquid cold and allergy products for children that were recalled Friday by drug giant McNeil Consumer Healthcare, according to a report issued late Tuesday by the U.S. Food and Drug Administration."
"Last Friday, McNeil initiated a voluntary recall of more than 40 products, including liquid Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl. These medications have been sold in the United States and 11 other countries. In all, about 1,500 lots of these products have been recalled."
"The company also closed its plant in Fort Washington, Pa., where the contaminated products were made. The plant remains closed and cannot reopen without FDA approval...." (excerpt continued at the end of this post)
Recall of Liquid Products for Children: What Consumers Need to KnowThe BusinessWeek article ends with a link to:
- "Recall of Liquid Products for Children: What Consumers Need to Know"
FDA: U. S. Food and Drug Administration
What is Wrong With These People?!I'm glad that somebody caught this problem, that the company involved cooperated and recalled its tainted products: and most particularly that THIS TIME NOBODY GOT KILLED.
Remember the poisoned peanuts?
I don't know details of what went so drastically wrong - in another American manufacturing plant. But this is getting to be a routine: poisoned peanut products; bacteria in hand sanitizers; and now childrens' cold remedies with some (as yet unknown) bacteria in the remedy.
Executives and managers may need a reminder that real people use their products. And even if we're not part of your social circle: our lives matter. To us, at least.
If this SNAFU is related to what I think is a root issue in the lethal peanuts caper: I think Congress may need a wake-up call, too. Startling as this may be: passing a law, or ordering some crazy regulation isn't the end of your responsibility.
I'm no big fan of regulation: not when it gets into 'let's think up crazy new warning labels' territory. (April 29, 2009, February 27, 2008)
On the other hand, I'm savvy enough to know that some abyssal fool of an executive is going to keep selling peanuts with deadly toxins added - unless somebody with enough muscle comes and sits on his/her head.
But - and somebody please tell those zanies we've got in Congress? You need inspectors to keep track of food and drug manufacturing. Startling, but true. And - here's where it may get a little hard to understand - inspectors need to be paid!
There's no point in being noble and compassionate and all that - if there isn't a budget to match those high ideals.
Excuse me: I need to calm down now.
- "Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadry: Children's Versions Recall - Product Recall Information"
(May 1, 2010)
- "Bacteria in Hand Sanitizers: Peanut Corporation of America's Sprit Lives On"
(August 4, 2009)
- "Peanut Peril: Remembering"
(February 26, 2009)
BusinessWeek excerpt, continued:
"...Speaking at a Tuesday afternoon press briefing, Deborah M. Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research, said that in February, the agency met with executives of McNeil Healthcare and its corporate parent Johnson & Johnson to complain about the company's manufacturing practices."
"McNeil had received 46 consumer complaints of foreign substances in its products, the FDA said."
"In mid-April, the FDA began its inspection of the plant and found "numerous deficiencies in the way products were manufactured and the way the manufacturing process for those products was controlled," Autor said. The inspection process finished Friday."
"These deficiencies included poor manufacturing practices and failure to maintain proper facilities and procedures for testing drugs, Autor said...."
There's more - I suggest you read the entire article.