Showing posts with label McNeil. Show all posts
Showing posts with label McNeil. Show all posts

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).

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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