Thursday, June 30, 2011

"McNeil's Quality Control 'STINKS' As Much As Its Tylenol Products Do" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"



Dear Ones:
     For a while now, we've been observing various problems with the McNeil company and their 'Tylenol', 'Benadryl', 'Zyrtec' and other brand lines.
     'Dust' in the facility, lacking or insufficient testing protocols, 'particulate matter' in their liquid products, 'off and moldy smelling products', 'superpotent' drugs, drugs with 'inactives' which haven't been properly tested, the use of raw materials known to be contaminated with gram negative bacteria...
LINK:  www.dearoneshealingministry.blogspot.com/2010/05/mcneil-childrens-drugs-fda-recall-camp.html

LINK:  www.dearoneshealingministry.blogspot.com/2010/05/fda-childrens-tylenol-recall-mcneil.html

LINK:  www.dearoneshealingministry.blogspot.com/2010/05/mcneil-tylenol-motrin-zyrtec-benadryl.html 

     The list of poor or lacking quality controls and assurances from McNeils goes on and on.
LINK: www.tylenol.com/page.jhtml?id=tylenol/news/main.inc

     Likewise "Good Manufacturing Practices' is something this company just cannot seem to wrap it's 'corporate culture' around and we are left to wonder why.
     Do they truly care so little for the consumer and so much for the almighty dollar that they consistently fail to assure us that their products are safe to use?
     We'll not find the answer at this time, but instead turn to a discussion of this 'stinky tablet' problem.
     In a sentence, 'skids' (also known as 'pallets') are wooden platforms upon which cases of 'finished product' are stacked prior to bulk 'shrinkwrapping'.
     The skids are picked up by fork-lifts and carried into large trucks for shipping all over the place.
     Skids can be made of either wood (the traditional way) or of compressed, molded recyclable plastic.
     Naturally, the 'wood ones' require some kind of preservative, as all wood does, in order that the wood maintain it's integrity and, therefore, it's strength.  The way to do this is to apply a suitable fungicide to the skids at the place they are manufactured.
     Fully loaded skids are heavy indeed.  If a skid 'collapses', it must be unloaded in place, which can be both a nuisance, and which can be dangerous if it blocks the flow of floor traffic.
     But the real danger is that it can cause it's load's center-of-balance to shift, thus causing it to become 'top-heavy' and come tumbling down, Heaven forbid, on a hapless warehouse worker or materials handler or passer-by!
     I mention this in order to emphasize how important it is to maintain 'good warehousing practices' at all times.
     The substance generally used for 'skids' is a stinky chemical known as TBA, which stands for 2,4,6-tribromoanisole.
     The best description I can give of it is that it smells like 'concentrated essence of vomit'  topped off with a good dollop of 'eau de dirty underwear'.
     Anyone familiar with warehouses knows how unpleasant it is to get a shipment of ANYTHING on 'new skids' in house.  You've got to keep the bay doors open and fans going in order to get that stink out...and it takes weeks, if not longer, for the smell to ever settle down.
     In fact, the most popular 'game played' is to get those 'new skids' out the shipping door as fast as possible so that some OTHER warehouse can have them while they 'age into respectability of smell'...not that anyone will actually admit they do this!
     Temperature is a factor, of course.  In the summer, it can get really bad in a non-temperature controlled facility with those stinky skids, on loading docks and in hot trucks.
     And the heat makes it all the more likely that anything placed on those skids will absorb the 'off odor' like crazy.
     Add to that that the packaging materials used (primarily plastic and paper) for most drugs and pharmaceuticals ALSO absorb 'off odors' easily.  AND on top of that, the 'final packaging' often involves heat processes (i.e. safety seals and shrink wrapping of all sorts) and you can imagine that you can have a real 'stinker' on your hands.
     And, wait, there's more!
      In certain instances, jars/bottles of non-tableted drugs and cosmetics are bottled or put in jars while still warm, which only prolongs the 'cool-down' period, and then you have real potential for the consumer to have a very unpleasant surprise when they finally open up their package.
     No doubt, the 'musty/moldy' odor in the Extra Strength Tylenol Caplets below came to be as a result of what I have just discussed above.  McNeil is no different than any other manufacturer when it comes to dealing with such issues.
     It is not uncommon to have to DEAL WITH odor issues, but it is UNACCEPTABLE to put such affected product out to market!
     And any concern who swears they 'didn't realize they had a problem'...needs to have their 'noses' examined!
     You will be told that, (although the odor is offensive) "the risk of serious adverse medical events is remote".
     This is true, although the TBA (2,4,6-tribromoanisole) itself most certainly is NOT.
     This benzene derivative is toxic and carcinogenic in the quantities skid manufacturers, chemists and others are likey to be exposed to.
     And a hot warehouse-full of smelly skids can definitely make one sick to one's stomach, as well as producing respiratory issues for those exposed to such a stench.
     That the McNeil people continue to have these 'off-odor' problems on top of all their other Q.C./Q.A. issues only reveals an entity that is NOT vitally concerned about the health and well-being of their customers...let alone their poor employees.
May God Bless & Keep You All
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com 


      McNeil Consumer Healthcare Announces Voluntary Recall Of One Product Lot Of TYLENOL® Extra Strength Caplets 225 Count Distributed In The U.S.

Contact:
Consumer:
1-888-222-6036
Media:
Marc Boston
215-273-7649 (office)
215-429-7034 (mobile)
Bonnie Jacobs
215-273-8994 (office)
856-912-9965 (mobile)
FOR IMMEDIATE RELEASE - June 28, 2011 - Fort Washington, PA – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling at the retail level one product lot (60,912 bottles) of TYLENOL®, Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recalled product was manufactured in February, 2009. McNeil is taking this action following a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).
This voluntary action is being taken as a precaution and the risk of serious adverse medical events is remote. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.
The product lot number for the recalled product can be found on the side of the bottle label.
FULL RECALLED PRODUCT LIST:
Product Name Lot Number UPC Code
TYLENOL®, Extra Strength Caplets, 225 count ABA619 300450444271
 
Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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