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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