Tuesday, May 4, 2010

Bacteria In Tylenol, Benadryl: What are These People Thinking?!

"FDA Found Bacteria in Ingredients for Recalled Tylenol, Benadryl"
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 Know

The BusinessWeek article ends with a link to:

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.

Related posts:
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.

2 comments:

mutuelle said...

Don't really wanna know...

Brian, aka Aluwir, aka Norski said...

mutelle,

I don't blame you. There's an old saying in English-speaking cultures, "ignorance is bliss."

I don't entirely agree - although not knowing about a lethal hazard can reduce anxiety. Until you start dying.

I suppose it's a matter of priorities: whether feeling good at the moment or living longer is more important.

Everybody else,

You've seen comments from "mutelle" and "Mutelle" before: "Remember When We were Doomed by the Coming Ice Age?," (January 17, 2010), for example.

My 'no spam' policy is still in effect: "mutelle" is just inside the envelope, for reasons I'll discuss in a moment.

Besides, in cases like this, I get to link to another post in this blog: It's an excuse for self-promotion!

The "mutelle/Mutelle" name links back to what appears to be an insurance service's website. So does the "mutelle santé" name.

The company's name translates as something like "Compare Mutual Health and Complementary Health Mutel." But my French is shaky, at best.

Despite my spam policy, I'm leaving these comments in place, since it's possible that an interested person is using Mutelle accounts to visit this blog.

Which may be within company policy: quite a number of employers have discovered that it's beneficial, in the long run, to let their employees stay in touch with the world and learn.

Which is yet another topic.

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