Recall of Tylenol, Motrin, etc.

[lector]

There is a huge recall underway involving Tylenol, Motrin, Benadryl, Simply Sleep, Rolaids & St. Joseph's Aspirin.

You can check your products here: http://www.mcneilproductrecall.com/index.jhtml

The website is not terribly clear on what you do if you have something that's part of the recall. That information is buried in the press release: they want you to call the toll-free #.

I'd never have known about this if not for the Haiti earthquake, which got me watching the 11:00 news last night.

The company claims that the contamination was caused by a chemical used to treat wooden pallets which volatized inside a "facility." (http://www.nytimes.com/aponline/2010/01/16/business/AP-US-Johnson-Johnson-Tylenol-Recall.html?_r=1) The mechanism of contamination is less than clear to me.

[GreenLines]

Huzzah for using generics. Thanks much for this, I'm sure a few here would be affected by this.

[theprestige]

Huzzah for using generics. Thanks much for this, I'm sure a few here would be affected by this.
You lost me. Are generics exempt from the possibility of product defects?

[GreenLines]

You lost me. Are generics exempt from the possibility of product defects?

No, just this particular recall.

ETA: What I meant by my post was that I don't have to go digging through my OTC meds to see if any are affected by this, since none of them are from the name brand mentioned as being affected.

[Travis]

Why is "facility" in scare quotes?

[lector]

Why is "facility" in scare quotes?

Why do quotation marks scare you?

[Travis]

Why do quotation marks scare you?

No, just seemed odd to quote that one word, as if you were implying it was something other than a facility.

[bruto]

No, just seemed odd to quote that one word, as if you were implying it was something other than a facility.In this case, I'd be more inclined (cynically, perhaps) to think "facility" is a euphemistic way for the manufacturer not to acknowledge under whose watch the problem occurred. If it had happened at some trucking company's warehouse, I bet they'd have named it. If it happened at their own factory, it's an unnamed "facility."

[lector]

OK. "Scare quotes" isn't a term I'm terribly familar with. Maybe it's a regional thing. Anyway, I thought that the NY Times did really shoddy & superficial reporting on the story; I was simply trying to emphasize that by quoting their term.

If it was a factory, why not say that & explain how the chemical transferred from the pallets to the pills? Or did it coat the bottles before they were fills with pills? If it was at a warehouse, then how did the chemical penetrate sealed bottles?

Even worse, the Times buried the story in the Business section & gave it a vague headline that wouldn't prompt anyone other than J&J stockholders to give it a second look. Seems a lousy way of publicizing a recall.

[Travis]

In this case, I'd be more inclined (cynically, perhaps) to think "facility" is a euphemistic way for the manufacturer not to acknowledge under whose watch the problem occurred. If it had happened at some trucking company's warehouse, I bet they'd have named it. If it happened at their own factory, it's an unnamed "facility."

That makes me wonder if they even know exactly where it did happen.

OK. "Scare quotes" isn't a term I'm terribly familar with. Maybe it's a regional thing. Anyway, I thought that the NY Times did really shoddy & superficial reporting on the story; I was simply trying to emphasize that by quoting their term.

If it was a factory, why not say that & explain how the chemical transferred from the pallets to the pills? Or did it coat the bottles before they were fills with pills? If it was at a warehouse, then how did the chemical penetrate sealed bottles?

Even worse, the Times buried the story in the Business section & gave it a vague headline that wouldn't prompt anyone other than J&J stockholders to give it a second look. Seems a lousy way of publicizing a recall.

I'm somewhat surprised at the coyness of it. J&J very responsibly made recalls back in the 80's and 90's.

[quadraginta]

OK. "Scare quotes" isn't a term I'm terribly familar with. Maybe it's a regional thing. Anyway, I thought that the NY Times did really shoddy & superficial reporting on the story; I was simply trying to emphasize that by quoting their term.

If it was a factory, why not say that & explain how the chemical transferred from the pallets to the pills? Or did it coat the bottles before they were fills with pills? If it was at a warehouse, then how did the chemical penetrate sealed bottles?

Even worse, the Times buried the story in the Business section & gave it a vague headline that wouldn't prompt anyone other than J&J stockholders to give it a second look. Seems a lousy way of publicizing a recall.


I'd like to know a bit more about this aspect, myself.

When I first heard about the recall, and the mention of contamination from pallets, that sent up red flares.

I have a little firsthand familiarity with procedures inside pharmaceutical production facilities, and a lot of experience with pallets. I'm pretty sure that they don't pour piles of loose pills on pallets :rolleyes:, and I can't think of any chemical treatments commonly applied to pallets which would pass through the multiple layers of packaging and still leave enough of a residue to be both harmful and generally undetectable by facilities QC, store employees, and consumers up to and beyond the point of actually consuming the product. Especially when it all ends up in a massive recall across a number of different products.

Something doesn't ring true. Or rather, something appears to be glossed over or left out.

[quadraginta]

Found this (http://www.securingpharma.com/40/articles/353.php). A little more detail.

FDA warning letter

To add to J&J's woes, the expanded recall - which now takes in a whopping 53 million individual products - is accompanied by a ticking off by the US Food and Drug Administration (FDA) for not responding quickly enough to the problem.

The contamination was caused by a chemical called 2, 4, 6,-tribromoanisole (TBA), itself a degradation product of a flame retardant (2,4,6, tribromophenol or TBP) used to treat wooden pallets used for transporting packaging materials and finished products.

It is thought that as a volatile compound, TBP was able to leach through the primary and secondary product packaging - cardboard and/or plastic bottles - and into the contents. This is an unusual case because where this form of leached contamination is encountered the culprit is usually the primary packaging itself.

A letter (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm197811.htm) sent to J&J by the FDA on January 8 censures the firm's quality control staff for not identifying the contamination quickly enough - despite complains stretching back to September 2008 - and delaying a recall for several months once it was identified

Forum scientists. Please comment.

If this is so potent and pervasive, why wasn't there an issue in the warehouse, before people started eating pills at home?

It occurs to me that the contamination may have been to a particular substance, such as acetaminophen, which had been on pallets for delivery to be included in other products, but that doesn't explain the recall of Rolaids, or St. Jo's aspirin.

I'm still having trouble understanding why an aerosol contamination by a volatile chemical didn't create a problem before it got to peoples' medicine cabinets if it was so potent that it could permeate all the packaging needed to load something on a pallet and still be dangerous to the point of making those people sick.

That level of disregard is much more worrisome than the recall itself.

[Beerina]

There have been no reports of nausea related to the most recent recall, the company said.


I'm sure that'll change shortly :rolleyes: