Showing posts with label Allergies. Show all posts
Showing posts with label Allergies. Show all posts

Monday, April 11, 2011

"Natural Asthma Treatments When Inhalers Fail Or Aren't An Option: THE ASTHMA CHRONICLES" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

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Dear Ones:
     Here are the very effective, natural supplements you can take to treat your asthma. These are recommendations for adults and for children over 12 years of age who are in good general health (besides being 'asthmatic') only.
TO STOP AN ASTHMA ATTACK IN IT'S TRACKS:

http://dearoneshealingministry.blogspot.com/2010/04/natural-asthma-treatments-part-three.html
 
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Natural Asthma Treatments- Part One 'In Light of FDA Inhaler Discontinuation' By Rev Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"
     Unfortunately, this in no way makes the 'medicinal CFC propellants' in asthma inhalers safe in any way, contrary to what physicians and pharmaceutical manufacturers will tell you. Trust me, I know only too well of the unknown dangers of ...
http://dearoneshealingministry.blogspot.com/2010/04/natural-asthma-treatments-part-one-in.html
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Natural Asthma Treatments-Part Two 'Your Hope & The Gameplan' By Rev Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"   Dear Ones:  Asthma is a very common 'condition'. Sometimes it is sporadic, with episodes being triggered, perhaps, by exposure to certain foods or odd air-borne allergens, such as fiber particles or certain 'dusts'. Sometimes it is 'chronic'...or can become chronic...depending upon what is done or not done, what is 'taken' or not taken. Sadly, sometimes asthma medications and treatments contribute to this revolving door effect. Anyone who is 'inhaler dependent' or has a child who is, knows the uncertainty and discomfort this causes. Pretty much, one's life revolves around "THE INHALER":
http://dearoneshealingministry.blogspot.com/2010/04/natural-asthma-treatments-part-two-your.html 

These articles have been provided for you by Rev. Barbara Sexton for your 'good health' combining the best of traditional and alternative medicine.
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Please understand that I am a biochemist and alternative healthcare provider with several decades of experience in the field of biomedical science. The information provided at http://www.dearoneshealingministry.blogspot.com/ and in any emails sent out by BarbaraKSexton@aol.com is for educational and entertainment purposes only and is in no way intended to replace the advice of your regular medical doctor or healthcare provider and you are urged to follow his/her advice. You are encouraged to share the contents at http://www.dearoneshealingministry.blogspot.com/  and of any e-mails specifically sent to you by Reverend Barbara Sexton, M.Sc. with your medical doctor and/or other healthcare providers with the understanding that all Intellectual Property Rights belong to Reverend Barbara Sexton, M.Sc. As such, this intellectual property may not be copied, transferred, transmitted, utilized or distributed by or for anyone else without my express permission and in accordance with all applicable laws. Any case-specific e-mails sent out by Reverend Barbara Sexton, M.Sc. are for the individuals for whom they are intended only and are subject to the Intellectual Property Rights restrictions above. Healthcare professionals may contact BarbaraKSexton@aol.com for terms, restrictions and fees (if any) if they wish to utilize this intellectual property for themselves or in their practices. Exceptions: FREE NEWSLETTER RECIPIENTS may share their copies with friends and family. Healthcare Professionals may sign up for the Dear Ones Healing Ministry NEWSLETTER by sending their name, address and email address to Reverend Barbara Sexton, M/Sc. at BarbaraKSexton@aol.com

Public Domain: This disclaimer published 3/8/10 on http://www.dearonesministry.blogspot.com/  
UPDATED: 4/11/11
Copyright 2009-2011
May God Bless You with abundant happiness & good health!--Rev. Barb

Wednesday, February 16, 2011

"Biochemist Recommends: Always Request Glove Changes You're Entitled To During TSA Pat-Downs!" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

TSA Pat-Down
Dear Ones:
     Well, I searched for it and here is a link on the TSA website which states that you have every RIGHT to ask TSA Officers to change their gloves when they touch your person and your property.
"You have the right to ask a Security Officer to change her/his gloves during the physical inspection of your accessible property, before performing a physical search (pat-down,) or any time a Security Officer handles your footwear." 
LINK: http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1567.shtm
     I have already discussed contamination and contagion possibilites at the hands of TSA agents
LINK: http://dearoneshealingministry.blogspot.com/2010/11/tsa-luggage-searches-infective.html 
     Regular 'glove changes' are prudent for travelers and TSA Officers alike.
     The only caveat is that since the gloves only cover up to the wrist, it is important to realize that any 'exudates', weeping/oozing fluids, bacteria, viruses, protozoans and so forth entrapped on the sleeves and other uniform parts of the TSA Officers (and on their bare skin for those wearing short sleeves) STILL HAVE THE POTENTIAL TO CAUSE PROBLEMS FOR YOU.
     Should any of the above contaminate you via the TSA Officer's clothes, you may be at risk, especially, should the contaminated uniform make contact with your eyes, mouth, nose, ears, broken skin, mucous membranes, 'rashy areas' and other 'areas'.
     Many microbes can live for an amazingly long time on so-called 'non-living surfaces' like clothing, pens, communication devices, clipboards, 'wands' and all the other items TSA Officers are likely to use when examining you.
     And the contamination potential can be even WORSE when the TSA Agent has bare arms which can carry not only fellow travelers' contamination, but his or her OWN population of bio-organisms, both pathogenic and non-pathogenic, as well!
TSA Pat-Down

     DON'T BE SHY!  ASK FOR A GLOVE CHANGE FOR THE FOLLOWING:
--before anyone handles and inspects your carry-ons
--after anyone handles your shoes and intends to continue
--after a TSA Officer touches their face/nose/mouth/ears/hair or anywhere else on their own body
--after anyone sneezes and/or coughs and/or has a runny nose and/or drools or 'splatters saliva while speaking' during your pat-down
--after a cast or brace is 'swabbed for explosives'.  It is virtually impossible to keep a cast or brace absolutely sterile and the swabbing procedure is essentially a 'microbe-collecting procedure' which will contaminate the TSA Officer's gloves no matter what he or she does.
--any time you feel uncomfortable with sanitation levels during your pat-down.
     Of course, these suggestions are as much for the benefit of the TSA Officers as they are for the traveling public.
     In an ideal world, TSA Officer's would be provided with new, clean disposable cover-ups and multiple sets of gloves for each and every passenger.
     If it were up to me, they would wear face masks, as well.
     But as it stands now, I suppose it will be necessary for some sort of airport and travel-related epidemic to break out before those safe-guards are in place.
     I've already written about 'Dominican Republic/Haitian Cholera' in New York City:
LINK: http://dearoneshealingministry.blogspot.com/2011/02/dohmh-officials-confirm-3-cases-of.html 
And about the emergence of Dengue Fever in the United States:
LINK:  http://dearoneshealingministry.blogspot.com/2010/08/dengue-fever-redux-socio-medical.html
     I also have a word or two for those with allergies.  Certainly, latex gloves themselves have a high allergenic potential for some people. 
     Please be sure to carry a note from your health care provider IF YOU ARE ALLERGIC TO LATEX and request the use of NON-LATEX GLOVES by any TSA Officers patting you down and touching your property.
     For those of you allergic to strong scents, be sure to request a 'glove change' whenever you suspect that a TSA Officer's gloves are contaminated with perfume or any other highly odoriferous substance.
      If the TSA Officer themselves has any overpowering odors themselves which are likely to aggravate your allergies, you may have to ask for a 'TSA Officer change', as well! 
    I imagine TSA Officers are counseled to not wear strong fragrance, etc and if not, they should be. 
     But in the course of the day, it is pretty likely that something or other from some one's Dopp kit will spill on a TSA Officer's clothing or work area, so you must be prepared to advocate for yourself if you or your loved ones have allergies. 
     I pray this information is of some help to you.  Please be sure to read all the 'tips' provided on the TSA Pat-Down Page entitled "Tips For The Screening Process":
LINK: http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1567.shtm
     They're good ones as we attempt to 'cope' with the realities of modern air travel in an uncertain world.
God Bless You & Bon Voyage
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com
BarbaraKSexton@aol.com 

Thursday, October 28, 2010

"Airmen Given Expired Anthrax Vaccines" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"


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Airmen Given Expired Anthrax Vaccines

All Air Force medical facilities stopped vaccinating against anthrax on Oct. 26 after officials determined that many treatment centers administered expired vaccines earlier in the same month. The only exceptions to the stand-down will be for personnel slated to deploy prior to Oct. 29 if the center can confirm that its vaccine supply is current.
More...
http://tracking.military.com/cgi-bin/outlog.cgi?url=http://www.military.com/news/article/airmen-given-expired-anthrax-vaccines.html?ESRC=eb.nl&code=101028DEBH01
I KNOW we can do better than this!
God Bless & Keep our Service Members
'RevUSABarb'
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com

Wednesday, October 27, 2010

"The Sudden BED BUG PROBLEM Explained" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

OUR LITTLE 'FRIENDS' Cimex lectularius
"All bedbugs mate by traumatic insemination.[3][20] Because the female has no genital opening, the male pierces her abdomen with his hypodermic genitalia and ejaculates into the body cavity. Male bedbugs sometimes attempt to mate with other males and pierce the latter in the abdomen.[21]"
Dear Ones:
     The exposition below is from an e-mail, which I believe to be quite accurate even if it only tells PART of the story!
     I have and I am doing extensive RESEARCH on this 'BED BUG PROBLEM' for you and will report on the same once this election season comes to a close, no worries.  My newfound political activism is the reason I have temporarily suspended distribution of my FREE NEWSLETTER.  (If you'd like to receive my FREE NEWLETTER for up-to-date health news in 'real time', just email me at BarbaraKSexton@aol.com with your name own email address.)
     For now I'll resist 'the urge' to suggest that this is anything more than a result of 'our global economy'.  But these little blood-suckers really ARE a health menace. 
     Don't you wonder how they suddenly FLARED UP in the UNITED STATES?
      I do.
For You in Christ,
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com
A bit of information that you might like to know about.
We have friends here in our community and one of their sons is an entomologist (insect expert), and has been telling them that there is an epidemic of bed bugs now occurring in America. Recently I have heard on the news that several stores in NYC have had to close due to bed bug problems, as well as a complete mall in New Jersey. He says that since much of our clothing, sheets, towels, etc. now comes from companies outside of America, (sad but true), even the most expensive stores sell foreign clothing from China, Indonesia, etc. The bed bugs are coming in on the clothing as these countries do not consider them a problem.


He recommends that if you buy any new clothing, even underwear and socks, sheets, towels, etc. that you bring them into the house and put them in your clothes dryer for at least 20 minutes. The heat will kill them and their eggs. DO NOT PURCHASE CLOTHES AND HANG THEM IN THE CLOSET FIRST. It does not matter what the price range is of the clothing, or if the outfit comes from the most expensive store known in the U.S. They still get shipments from these countries and the bugs can come in a box of scarves or anything else for that matter. That is the reason why so many stores, many of them clothing stores have had to shut down in NYC and other places. All you need is to bring one item into the house that has bugs or eggs and you will go to hell and back trying to get rid of them. He travels all over the country as an advisor to many of these stores, as prevention and after they have the problem.

From e-mail.  THANK YOU UNCLE CHARLIE--You're the BEST!
Love & Blessings,
Barb

Thursday, September 30, 2010

'Suzipoo Issues Allergy Alert on Undeclared Allergen in Lobster Poo' By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

"Anything living in the water that does not have fins and scales is to be detestable to you."                      Leviticus 11:12 (NIV)

(Note: this is an actual FDA recall.  No need to ask how I came across it : )
Suzipoo Issues Allergy Alert on Undeclared Allergen in Lobster Poo

Contact:
Sue Pollard
207-251-0523
FOR IMMEDIATE RELEASE - September 22, 2010 - Suzipoo Ogunquit, Maine is voluntarily recalling Suzipoo Lobster Poo, 4 oz bags, because it may contain undeclared peanuts. People who have an allergy or severe sensitivity run the risk of serious or life-threatening allergic reaction if they consume these products.


The product is in a small plastic bag with a red bow on the bag and the label on the front reads. "Lobster Poo" – Slogan – I went to Maine and here's the scoop I came back home with Lobster Poop.


Product was distributed to three retail stores in Maine from August 1-August 18, 2010. Each store has been visited and product labeling has been corrected. Ten- 4 oz. bags may be incorrectly labeled.


No illnesses have been reported to date.


The recall was initiated after it was discovered that product (burnt red peanuts) was distributed in packaging that did not reveal the presence of peanuts.


Consumers who have purchased the product are urged to return it to the place of purchase for a refund. Consumers with questions may contact the company at 1-207-251-0523.

     Alright.  I will admit that the life of anyone working in 'regulatory affairs' in the food and drug industries can be and often is a rather pedantic and even boring one.
     Then, once in a while something like this comes along.   An amusement,perhaps, to the overseer, but NOT much fun for anyone who happens to be allergic to peanuts.
     Apparently, the product is not really 'lobster poo', though neither is it labeled as 'the burnt red peanuts' that it actually is.
     For those whose faith impels them to subscribe to the rules laid out in Leviticus of the Old Testament,  I'm pretty sure that the lobster and any actual lobster poo both fall under the same dietary restriction.
     That would be my pronouncement, anyway.
Blessings,
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/

Thursday, May 13, 2010

Reverend Barb's Guide To Safe Produce Eating By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

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Dear Ones:
If you read my articles or get my NEWSLETTER, you know that I make it my business to stay on top of any and all food, drug, herb, supplement and medical device 'recalls'.  I thought it might be interesting for you to learn exactly what I do to protect my own health and those of my loved ones on a daily basis when it comes to PRODUCE and here it is:


1)    I check for current recall news at http://www.fda.gov/, http://www.cdc.gov/ and at http://www.cdc.gov/mmwr/ and any and all academic and news sources, as necessary.


2)  I LOOK at the quality of the produce I am buying.  I do the old 'COA'-color, odor, and appearance check.

3)  I CHECK the quality and integrity of the packaging, if there is any.

4)  I tend to 'skip' the open salad bars.  I bypass produce piles at shoulder level where people will cough and sneeze on them. 

5)   I WASH everything I buy, even if it says 'already washed'.  Use massive amounts of fresh running water. 'Hard produce' like potatoes get a scrubbing with a brush and a bit of some non-perfumey liquid soap/detergent. It is difficult to adequately disinfect berries and soft produce, so eating them is something of an act of faith. Personally, I test out a few lettuce leaves (for example) as I am making dinner. Any dessert fruit, too!

6)  If any produce doesn't look right, taste right or if the package is breached, I THROW it out! Please don't feed suspect produce to the critters outside, for if the produce can harm you, it can harm them as well. All mammalian systems are designed by the Great Designer and Creator to live with and depend upon 'good microbes'. But the microbes often in question are the harmful 'pathogens'.   In the case of lettuce, they are a bacterial strain of the intestinal E. coli gone bad. Be sure to dispose of bad produce properly, so that it is sure to not get into anyone's 'food supply chain', anywhere.

7)YES 'one is CONTAGIOUS' when infected with E.coli O145 or some other bacteria or protozoan (or even virus if someone with the flu sneezes on your store's broccoli section) etc, as far as their feces are concerned.  So DO practice good toilet and hand hygiene at all times.

8) I use gloves when handling food for my family, especially since I cook for cancer survivors, immunocompromised persons and those who are, at times, post-operative. Also, if you have any open wound on your hands, protect it from being contaminated by food, again by wearing gloves.  I recommend and use non-latex gloves.  You may not have a problem with latex, but you may be handling the food of someone who is.  Just remember that 'gloves can get contaminated, too'. I wash my gloved hands, too, as needed, and ditch and replace gloves after handling raw meat, fish, or anything greasy or oily. This may sound like a lot of waste, but it really helps.  Be sure to properly dispose of gloves, of course, and use paper towels for contaminated 'spills' with proper disposal too!

9) Report any significant produce problems to the manager at your grocery store or restaurant.  He or she will be most appreciative for the input.  In this day and age of terrorism, threats to our 'food supply'...bulk, especially...have been a very real and on-going concern as we have received bonafide threats and learned of 'food-contamination' plans.  It goes without saying that you must alert the authorities immediately if you witness anyone tampering with anything at all in any food store.  Do so without jeopardizing your own safety, of course.  After notifying store and law officials, you may also report directly:
CRIMINAL ACTIVITY REPORT: http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm

EMERGENCY(serious, life-threatening food-related event) : FDA's 24-hour emergency line at 301-443-1240 OR FDA Consumer Complaint Coordinator3 in your geographic area: http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm  
Also contact your health care professional for medical, of course

NON-EMERGENCY Food-related (such as allergic reaction to a product with no allergens listed in ingredients; a non-life-threatening foodborne illness) in food products (except meat, poultry, and frozen, dried and liquid eggs) FDA Consumer Complaint Coordinator6 in your geographic area.

http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm

ANIMAL FOOD PROBLEM-Pet food, animal feed http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm
I hope these hints help you out in protecting the health of yourself and those around you.  As always, be sure to seek the advice of your physician or other health care provider for any and all health concerns.  But remember that your 'everyday well-being' depends largely upon YOU!
God Bless You Today and Always,
Reverend Barbara Sexton
www.DearOnesHealingMinistry.blogspot.com

 
 
 
 
 
 
 
 
 
 
 

Wednesday, May 5, 2010

McNEIL Children's Drugs FDA Recall: Camp 'Runamuck' DETAILS Explained For You By Rev Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

     Oh boy.  Things are MUCH WORSE than they appeared at first blush with the recent McNeil Children's Drugs Recall.   From the FDA Inspection Report at the McNeil plant in Fort Washington, PA,  it has become obvious that McNeil's quality control problems are SEVERE.  According to the FDA field inspection reports, McNeil KNOWINGLY used raw materials that they KNEW were contaminated with BACTERIA.  This, dear Readers, is simply unconscionable.  Here are the highlights of the Inspection Report. MY TAKE IS IN CAPS, followed by the official FDA "Observations".
1)  GRAM NEGATIVE ORGANISMS (BACTERIA) FOUND IN TYLENOL RAW  MATERIALS "The responsibilities and procedures applicable to the quality control unit are not fully followed.
2)  MCNEIL HAS LITTLE OR NO QUALITY CONTROL PROCEDURES AND DOES NOT CONFORM TO CGMP'S ('CURRENT GOOD MANUFACTURING PRACTICES') "There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess." MORE SPECIFICALLY: "It (McNeil)  does not maintain adequate laboratory facilities or e stmg an approval (or rejection) of components and drug products; it neglects review and approval of validation protocols regarding changes in product processes and equipment to determine when revalidation is or should be warranted; it is default in investigations, tracking, trending and maintenance of consumer complaint follow-up; and it lacks trending ofproducts, components (i.e., water), and complaints to demonStrate a broad perspective to assure plant conformance with CGMPs."
3)BAD MIXING MANUFACTURING PRACTICES "Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity."
4) NO WRITTEN QUALITY CONTROL RECORDS DURING MANUFACTURING (NO IN-LINE TESTING) "Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product."
5) NO CUSTOMER COMPLAINT FILES/CORRECTIVE ACTIONS/RESPONSE FOR COMPLAINTS OF PRODUCT WITH  FOREIGN MATERIAL, PARTICULATE MATTER AND/OR CONTAMINATION. "Written production and process control procedures are not followed in the execution ofproduction and process control functions"
6) NO ASSURANCE OR INVESTIGATION OF QUALITY, PURITY, ETC FOR FINISHED PRODUCTS DESTINED TO BE ADMINISTERED TO CHILDREN WITH KNOWN RAW MATERIAL BACTERIAL CONTAMINATION.  MCNEIL RELEASED FOR SALE THESE PRODUCTS ANYWAY! "There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."
7) NO GMP (GOOD MANUFACTURING PRACTICES) TRAINING...NOT MANY GMP'S FOR THAT MATTER, EITHER ACCORDING TO THESE FDA OBSERVATIONS. "GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them."
8) NO CUSTOMER COMPLAINT FILES "Procedures describing the handling of all written and oral complaints regarding a drug product are not followed"
9) NO SECOND PERSON 'SIGNING OFF' ON MANUFACTURING CHECKLISTS (IF MCNEIL HAD CHECKLISTS, THAT IS)  "Each container of component dispensed to manufacturing is not examined by a second person to assure that the weight or measure is correct as stated in the batch records."
10) BAD LABELING AND LABELING PRACTICES  "Strict control is not exercised over labeling issued for use in drug product labeling operations."
11) NO STABILITY TESTING (WHICH KIND OF RENDERS MY 'TESTING OF RETAINED SAMPLES SOMEWHAT MOOT) "There is no written testing program designed to assess the stability characteristics of drug products."
12) NO LAB PRODUCT QUALITY STANDARDS (SPECIFICATIONS, AND SOP'S-STANDARD OPERATING PROCEDURES) TO ASSURE BATCH-TO-BATCH CONSISTENCY  AS JUDGED AGAINST 'APPROVED SAMPLES' OF A GIVEN PRODUCT) "Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity."
13) BAD LAMINAR FLOW HOODS/FILTERS, NO OR INSUFFICIENT MICRO WORK, DIRT/LACK OF CLEANING/NO LOG IN RAW MATERIAL WEIGH AREA, DUST, DIRT, DEBRIS, DUCT TAPE, "GREY/BROWN DUST ON INCUBATOR BOTTOMS, BAD ASEPTIC TECHNIQUE BY MICROBIOLOGISTS AND MORE  "Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit."
14) LAB REFRIGERATORS NOT CALIBRATED PROPERLY Laboratory records do not include complete records of the periodic calibration of laboratory instruments, gauges, and recording devices.
15) SOP (STANDARD OPERATING PROCEDURE) PROBLEMS WITH MICRO SAMPLING SWABS FOR CLEANED EQUIP, LACK OF APPROPRIATE COLONY-COUNTING STANDARDS, ETC. "Written specifications for laboratory controls do not include a description of the sampling procedures used."
16) IGNORING THE QUALITY CONTROL RULE TO 'TAKE YOUR OWN SAMPLES AND USE APPROPRIATE SAMPLING METHOD(S)', MCNEIL HAD RAW MATERIAL MANUFACTURERS PULL (INSUFFICIENT) SAMPLES FOR THEM "Samples taken of in-process materials for determination of conformance to specifications are not representative.
17)WHAT'S WHAT AT MCNEIL? LEAKING BAGS, TOO. "Each lot of components,was not appropriately identified as to its status in terms of being quarantined, approved or rejected."
18) NO MICRO TESTING ON WATER USED "Components are not microscopically examined when appropriate."
19) NO CLEANING & MORE 'GREY-BROWN DUST' "Records are not kept for the maintenance and inspection of equipment"
20) LACK OF CHECKLIST/SIGN-OFF'S "The persons double-checkng the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log"
 Read it  first hand here:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM210772.pdf
 The main page for the McNeil Tylenol, Motrin, Zyrtec and recall is found here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210441.htm
     I have many years of first hand experience working with FDA inspectors breathing down my neck (they literally 'dog you' every minute of the day)...and God Bless them for doing it!  Here is an example of a very valuable service the FDA performs on behalf of the public!  I don't always think so highly of them, but in this case, the FDA is 'dead on'. 
     I'm sorry to say this, but at this point I would be skeptical about ANYTHING McNeil has to say on it's own behalf,  unless and until their claims are fully verified by repeated, independent testing.
      The FDA will need to do what they do in cases like this, which will likely include the following, based on what I know about these things:
---Test every 'raw material' in house now for microbial contamination and to see if it meets specifications chemically
---Test every in-line product and final products in house now and test as above.
---Test all 'retained samples' of raw materials, in-line products and final products and all packaging, as above, going back as many years as the FDA Inspectors see fit.
---Have independent labs repeat all FDA testing
---Mandate that McNeil have independent testing done on all applicable samples also by 2+ independent labs.
      I think you get the idea.  It will be a major job.  Your job is to not use any of these products until further notice.  I will update you as appropriate.
     It's difficult to not 'stand in judgment' of the shoddy QC practices and other practices exhibited by McNeil.  God only knows what they've been thinking, to attempt to 'get away' with things as they are and have been.
     Don't forget that many pets are given 'human' medications, too.  God forbid that a child, adult or beloved pet has been harmed in any way by the negligence and lack of caring demonstrated by McNeil. 
With prayers for your health and safety with a plea for McNeil to 'come clean' on all of this--
I am,
Rev Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/

Tuesday, May 4, 2010

FDA Children's Tylenol Recall McNeil: Alternatives For Concerned Parents By Rev Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

My Dear Ones:

     I see that many of you are so very concerned about the recent FDA Recall of McNeil Children's Products including Tylenol, Motrin, Benadryl and Zyrtec. I apologize for not following up soon enough with 'alternative suggestions'. I wrongly assumed that you would get timely advice from your health care providers. Please remember that many 'docs' nowadays have excellent websites with support personnel standing by to respond to you. Please do consult with them in all situations such as these and don't give up on them!
     My advice for all concerned parents is to USE THE ALTERNATIVE GENERIC FORMS of the McNeil pharmaceuticals that have been recalled. Please read my disclaimer at the bottom of this page and consult your physician. I will follow-up with some Alternative Medicine pediatric suggestions for you, also.
     It you were to consult with me, I would recommend Motrin instead of Tylenol. In other words, I would suggest ibuprofen instead of acetaminophen. As always, let your pocketbook be your guide as you follow the dosing advice of your pediatrician or other health care advisors.
     I advise against Zyrtec and use and recommend Benadryl-like (diphenhydramine) products instead.  I recommend the capsule form, which can be swallowed or 'crushed, mixed into applesauce or yogurt' and taken that way.
     Many prescription pharmaceuticals enjoy popularity and then fade into obscurity. That may be the case with 'Zyrtec', which I do not like. Use diphenhydramine and pseudoephedrine, instead, for allergy relief.
     McNeil will eventually get a control on it's 'Quality Control Problems' (an area of my expertise), but you need to use your common sense in order to care for your children.
     Please check in here regularly so that you can protect the health of all your loved ones as you consult your doctor in your attempts to protect your family.
God Bless You As You Decide What's Right For Your Family  in the Popular Media today.
With Love in Christ,
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/

Saturday, May 1, 2010

McNeil Tylenol, Motrin, Zyrtec, Benadryl FDA RECALL-My Comments & Suggestions By Rev Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross" www.DearOnesHealingMinistry.blogspot.com

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Dear Ones:
     "Well...I never liked them anyway."  This is what some of you have heard me say time and time again over the years.  I'm referring to Tylenol and Zyrtec.  Motrin (Ibuprofen) and Benadryl (diphenhydramine) are a little better, but these ALL have to go for now. My comments and suggestions are in red.
 Here is the McNeil recall notice from the FDA:
http://www.fda.gov/Safety/Recalls/ucm210443.htm
McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

FOR IMMEDIATE RELEASE - April 30, 2010 – Fort Washington, PA. McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW).

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use....read the rest here:
McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

...read the rest here
http://www.fda.gov/Safety/Recalls/ucm210443.htm OR stay here and read the original McNeil Recall Letter below in it's entirety.
     But first, here's the DRUG LIST of the recalled products.  DO NOT USE THEM!  Tylenol is also known as acetaminophen, paracetamol and N-acetyl-p-aminophenol (APAP).  I never promote the use of this drug, for it is too toxic.
     Tylenol for infants and children is so very toxic to young livers and to older ones, too, especially in those who drink alcohol.
     The official toxic dose for adults is 4,000 mg, and less for those who imbibe or have other predisposing factors.
     In children, the toxic dose which will destroy the liver is so low that even one overdose can kill.  Consult your doctor or health care provider for specific advice.
     Tylenol destroys the liver by depleting it's glutathione stores to the point that the liver dies.  Fortunately, for adults, I can recommend the use of glutathione-restoring NAC, N-Acetyl-Cysteine to protect your liver.  If you use Tylenol products and/or enjoy cocktail hour, take one 600 mg capsule of NAC before bedtime each night.  I will discuss using NAC for other liver conditions such as cirrhosis and hepatitis another time.  Consult your pediatrician or other health care professional for use of NAC in children under 12.
     The other natural supplement to use if you take Tylenol and/or enjoy cocktail hour is Milk Thistle extract.  Take one-three doses per day for serious liver disease in adults, either the liquid extract as directed on the label or one-three capsules of Milk Thistle extract (70 mg per cap) per day.  Consult your pediatrician or health care provider for the pediatric doses. 
     These items are available below or see my complete Rev Barb's Store with items I have hand-picked for you to protect your health:  http://astore.amazon.com/deaoneheamin-20 CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR 50580-144-01
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR* 50580-144-15
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE 50580-167-01
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR 50580-143-15
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR 50580-143-30
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE - HOSPITAL 50580-144-18
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE - SAMPLE 50580-144-40
CHILDREN’S TYLENOL® SUSPENSIONS
CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR 50580-123-02
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR 50580-123-04
CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR 50580-166-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH 50580-296-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-407-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR 50580-493-04
CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE 50580-123-01
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL 50580-123-03
CHILDREN’S TYLENOL® PLUS SUSPENSIONS
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR 50580-247-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR 50580-249-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR 50580-253-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR 50580-254-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-255-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR 50580-386-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR 50580-387-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR 50580-390-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-391-04
MOTRIN® INFANTS’ DROPS
CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE 50580-198-01
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE 50580-198-15
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR* 50580-100-15
CHILDREN’S MOTRIN® SUSPENSIONS
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE 50580-184-04
CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR 50580-601-02
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR 50580-601-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR 50580-215-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR 50580-603-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-604-04
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE 50580-603-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE 50580-604-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE 50580-601-01
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL 50580-601-50
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR 50580-902-04
CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES
CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP 50580-721-04
CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP 50580-730-04
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE 50580-730-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM 50580-721-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID 50580-721-08
CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES
CHILDREN'S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID 50580-535-04
* CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR is also included in JOHNSON'S ® Baby Relief Kit.
*CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR is also included in JOHNSON'S ® Baby Relief Kit
Here is the original McNeil Recall Letter from:
http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc
McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children's Products

Fort Washington, PA (April 30, 2010) – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW). Rev Barb's comments are in red:
McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. (YET!) However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient (greatly increasing the threat of overdose!) than is specified; others may contain inactive ingredients that may not meet internal testing requirements; (And Lord knows what this means.  McNeil need to disclose more) and others may contain tiny particles(Again, this is anybody's guess) While the potential for serious medical events is remote, (WRONG!  Given the frequency of Tylenol overdose in children and the high toxicity of this drug, as a Biochemist I completely disagree with this assertion.  And, I would like to know what the 'extra inactive ingredients' mentioned here are and what are those 'particles' the FDA mentions in its Recall Notice?) the company advises consumers who have purchased these recalled products to discontinue use.
The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.
Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.
For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products. From: http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc
     As I stated already, I have a problem with some of these drugs.  Let's say you give your allergic child the antihistamine Benadryl (diphenhydramine).   And let's say this child is, say hyperactive or has ADHD or has food allergies or is hypoglycemic or diabetic or just has a sensitive constitution.  Giving that child artificial flavorings and colorings alone can defeat the so-called antihistamine activity of Benadryl....and can even make any allergic reaction WORSE.  So far, not many medical doctors realize or acknowledge this, and as parents the responsibility rests with you to keep your children protected.
     That's it for now on this recall and I will update you as needed.  If you'd like to sign up for my FREE NEWSLETTER and get articles like this in your mailbox immediately, just let me know by email that you'd like to sign up: BarbaraKSexton@aol.com
God Bless and Keep You Happy and Healthy,
With Love in Christ,
Rev Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com

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