Recall PediaCare Blacksmith Brands Children's Cold & Cough Medicine

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FDA NEWS: June 1, 2010.

FDA Alert:
Blacksmith Brands initiated the recall as a precautionary step because the products were manufactued at a McNeil plant in which a recent FDA inspection found serious problems in meeting FDA's current good manufacturing practice requirements. The company advises consumers who have purchased these recalled products to discontinue use.

PediaCare Multi-Symptom Cold
PediaCare Long Acting Cough
PediaCare Decongestant
PediaCare Allergy and Cold

-------------end of PediaCare Children's Product Recall--------

FDA NEWS: May 3, 2010.

The makers of children medications Johnson and Johnson's McNeil Division has recalled 43 different forms of Tylenol, Motrin, Zyrtec, and Benadryl citing manufacturing defects. No injuries or deaths have been reported.

This is voluntary recall after a FDA inspection back on April 19 that investigators uncovered manufacturing deficiencies at the McNeil plant.

It is not known how many units were being recalled.

The company put out this statement. "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,".

List of Recalled Children’s medicines

TYLENOL INFANTS' DROPS
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. GRAPE FLAVOR
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. GRAPE FLAVOR
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. CHERRY DYE FREE
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. CHERRY FLAVOR
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. CHERRY FLAVOR
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. GRAPE – HOSPITAL
CONCENTRATED TYLENOL INFANTS' DROPS 0.25 OZ. GRAPE – SAMPLE
CHILDREN'S TYLENOL SUSPENSIONS
CHILDREN'S TYLENOL SUSPENSION 2 OZ. CHERRY BLAST FLAVOR
CHILDREN'S TYLENOL SUSPENSION 4 OZ. CHERRY BLAST FLAVOR
CHILDREN'S TYLENOL DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR
CHILDREN'S TYLENOL SUSPENSION 4 OZ. GRAPE SPLASH
CHILDREN'S TYLENOL SUSPENSION 4 OZ. BUBBLEGUM FLAVOR
CHILDREN'S TYLENOL SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR
CHILDREN'S TYLENOL SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE
CHILDREN'S TYLENOL SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL
CHILDREN'S TYLENOL PLUS SUSPENSIONS
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR
MOTRIN INFANTS' DROPS
CONCENTRATED MOTRIN INFANTS' DROPS 1 OZ. BERRY DYE FREE
CONCENTRATED MOTRIN INFANTS' DROPS 0.5 OZ. BERRY DYE FREE
CONCENTRATED MOTRIN INFANTS' DROPS 0.5 OZ. BERRY FLAVOR
CHILDREN'S MOTRIN SUSPENSIONS
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY DYE FREE
CHILDREN'S MOTRIN SUSPENSION 2 OZ. BERRY FLAVOR
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY FLAVOR
CHILDREN'S MOTRIN SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR
CHILDREN'S MOTRIN SUSPENSION 4 OZ. GRAPE FLAVOR
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BUBBLEGUM FLAVOR
CHILDREN'S MOTRIN SUSPENSION 1 OZ. GRAPE SAMPLE
CHILDREN'S MOTRIN SUSPENSION 1 OZ. BUBBLEGUM SAMPLE
CHILDREN'S MOTRIN SUSPENSION 1 OZ. BERRY SAMPLE
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY HOSPITAL
CHILDREN'S MOTRIN SUSPENSION 4 OZ. COLD BERRY FLAVOR
CHILDREN'S ZYRTEC LIQUIDS IN BOTTLES
CHILDREN'S ZYRTEC 4 OZ. BUBBLEGUM SYRUP
CHILDREN'S ZYRTEC DYE FREE 4 OZ. GRAPE SYRUP
CHILDREN'S ZYRTEC SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE
CHILDREN'S ZYRTEC SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM
CHILDREN'S ZYRTEC SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID
CHILDREN'S BENADRYL ALLERGY LIQUIDS IN BOTTLES
CHILDREN'S BENADRYL ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID

 

ION Labs and FDA notified consumers and healthcare professionals of the recall of all Influend Cough and Cold products sold on or after May 30, 2008 due to the possibility that the products may be superpotent with possible complications ranging from tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension to headaches, dizziness, anxiety, restlessness and nervousness. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. FDA Link: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Influend

FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur.

FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed.

FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory and a previous MedWatch alert dated January 12, 2007, regarding this issue.

FDA Website link:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough

Johnson & Johnson Wyeth and other makers of nonprescription cough and cold medicines issues recall on these products due to possible overdose concerns in children under 2 years of age.

Brands that are recalled include:

Concentrated Infants' TYLENOL Drops Plus Cold;

Concentrated Infants' TYLENOL Drops Plus Cold & Cough;

PEDIACARE Infant Drops Decongestant (PSE);

PEDIACARE Infant Drops Decongestant & Cough (PSE);

PEDIACARE Infant Dropper Decongestant (PE);

PEDIACARE Infant Dropper Long-Acting Cough;

PEDIACARE Infant Dropper Decongestant & Cough (PE) products;

Dimetapp Decongestant Plus Cough Infant Drops;

Demetapp Decongestant Infant Drops;

Little Colds Decongestant Plus Cough;

Little Colds Multi-Symptom Cold Formula;

Robitussin Infant Cough DM Drops;

Triaminic Infant & Toddler Thin Strips Decongestant and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.

Overdose concerns:

Even though the The FDA recommends that over-the-counter cough and cold medicines that have decongestants and antihistamines should have labels with instructions illustrating that they should not be given to very young children.

U.S. Government officials are reviewing the safety and efficacy of a number of over-the-counter children’s cough and cold medications in order to determine if they pose a threat.  Many healthcare professional groups maintain that these drugs no only do not treat the symptoms of many common children’s ailments, but can also be dangerous to a broad cross section of young people.  In fact, the Centers for Disease Control and Prevention reported that more than 1,500 toddlers and babies had to receive emergency room treatment over two years due to these kinds of drugs.

In a response to a petition filed by the Baltimore city officials on Thursday, March 22, Dr. Charles Ganley, director of the Food and Drug Administration’s Office of Nonprescription Drug Products, stated, "We have been looking at this issue internally with regard to the safety and efficacy of the use of these products in children."  The new review covers decongestants, antihistamines, cough suppressants and expectorants.

Although the warning labels on products such as Tylenol Plus Cold & Cough and Infant Triaminic Thin Strips explicitly state that they parents should consult a doctor before giving medicine to children younger than two years old, the packaging of the same drugs uses languages such as “infant” or “baby” and also often portrays children of a much younger age than the recommended by the warnings.

In Maryland, where many of the sponsors of the petition reside, almost 900 children four years and younger suffered overdoses of cold medicines in 2004, and in Baltimore these products were linked to the deaths of at least four children over the past five years. 

Startlingly, there have never been any conclusive studies that children’s cough and cold medications have any effect on the myriad common colds that strike children each year.  This, along with the startling injury rate, promoted concerned citizens to speak up and demand new safety precautions for these common over-the-counter drugs.

If your child has been been harmed or has overdosed from taking any of the above listed medicines, please contact our defective drug lawyer today for a free review of the situation. Attorneys working to make sure these companies are issuing safe medicines.

Search phrases related to this document include:

Cough and cold Recall

Recalls on children's cold medicine

Injury Death Lawyer Lawyers Lawsuit lawsuits Dangers Side effects Reactions Attorney Attorneys

Defective Drugs: News, Statistics and Legal Guide

dthodgesays: 2011-11-03 07:46:11

My daughter took 1 10mg zyrtec chewable and within an hour she was having head pain, within 5 hours she had a seizure and was completely incoherent for about 10 min, then she was left with crippling head pain. After all tests at the ER showed NO problems and the follow up 36hrs later confirmed I realized it was the citirizine. I will not give my children this ever again. Very scary.

Tinasays: 2010-11-01 20:47:28

My grandson had a barking frequent cough and congestion. I gave him Triaminic thin strips. He went to sleep with out a problem. I tried to move him a hour later. He awoke delirious. in fact every time he was stimulted he would scream wide eyed trying to run away as if he did not know me. Be careful with these meds!

Cynthiasays: 2010-09-16 19:36:17

I gave my son DG children's acetaminophen, cherry flavor. After having an arm ache in the middle of the night. He began seeing colors and started to have Mania. Bad thoughts of hurting himself and others and animals. He couldn't sleep, and he cried because "I would never hurt anything" he said, "help mommy my brain hurts" more crying. He started to feel better, and then came down with a fever. I dosed him half of the called for amount for a four year old his size, to be on the safe side. Within minutes he began crying and having horrible thoughts. It was awful!! I knew right then what was causing the problem. I told him it was the Acetaminophen, and it would probably take a few days to wear off. I was right! After only two days he's feeling bad to almost normal, but very exhausted. Just laying around, and his memory is not what it was, and he's still staggering and rolling his eyes, and vomiting, but so far no talk of hurting anything. Just back to sweet and loving, but so tired. We have an appointment tomorrow. I want to ring these peoples neck! This is our child you're messing with. They say there are not reported effects on children. It�??s just voluntary, and the concentrations are exceeded, which could produce vomiting. That means liver damage, and my son could be harmed psychologically as well. What if I�??d given him the whole dose amount?!! I�??m so angry!!! You don�??t send this stuff out until you KNOW what you�??re giving babies and children, unless it�??s intentional.

mellanysays: 2010-07-20 15:12:54

Keep tylenol cough and cold away from your kids. My 6 year old was taking it. She ended seizuring and loss of breathing. At one point I saw nurses and doctors looking for her pulse. We never got complete answers but she was taking cough and cold. We didn't have answers because her seizures we too long more than 4 in a day and abnormally on one side. No answers given. All we know is that she was on Cough and Cold.

amanda maxonsays: 2010-07-18 17:55:21

My daughter who is 5 was taking the tylenols for a fever and after they were recalled and I stopped giving her the tylenols she started getting spiratic fevers with no other symptoms. The doctors thought it had something to do with her urine and sent her for a test at the hospital, that test came back good. The blood work came back good also. McNeil requested her medical records because we have no clue what is causing the spiratic fevers. Since not taking the tylenol though the fevers have gone away. I personally think it is linked to the tylenol, but will McNeil ever admit to that? Probably not, I haven't heard from them since I signed the release of my daughters medical records.

Atina Gatewoodsays: 2010-07-01 19:56:14

My son had a fever so I gave him Tylenol and within minutes he had a seizure and he would not come to he had to taking to hospital. He was out for many hours. This has happened more than one time.

April Langesays: 2010-06-15 10:50:56

My daughter has been taking this tylenol and the bottle is almost gone. I had no idea about the recall- she has had bladder infections and rashes and today I cried because if I had know that it was the tylenol's fault I would have stopped using it. I hope there are no last effects.

Michaelsays: 2010-05-27 07:53:26

I have 3 kids.....My daughter has had severe bladder infection for a year now and bad head aches....we wefre giving her tylonol childrens...she has been to the doctors hundred times and been on antibiotics for over year....They cantt get rid of it....My son has been to memergency room many times for trouble breathing and other problems....since the recazll and we stopped using tylonol childrens...my boy has got better....but my 6 yr old daughter has permenant damage to her kidney and bladder and still going to dovtor....Please help....i am 100% sure this is what made my kids sick......what do we do?

Trishsays: 2010-05-21 06:32:41

I have given my 2yr old son Motrin, Tylenol and Zyrtec with no issues or side effects. While I think the recall is important it's not something I'm going to get worked up over. I feel that in today's society everyone freaks out over the little things just because someone elses child had a side effect. I'm sure I'll get some nasty comments but that is my opinion. As I will limit the use of OTC medicine with my son I will continue to use some in order for my son to not suffer fro allergies or fevers when sick.

Veronica Nicholassays: 2010-05-15 15:13:36

My Daughter is 29 months and has been taking Zyrtec for the past year in half.It scares me to know that this medicine has been on the store shelves for so long. I just hope and pray in the long run my baby don't any medical problams.

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FDA Alert Recall on PediaCare Blacksmith Brands Children's Cold & Cough Medicine: Overdose warning - updated 3/06/2013