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Hylands Teething Tablet Recall: FDA, Homeopathic Voluntary Recall
Homeopathic Hyland's Teething Tablet Recall After: Adverse Affects Reported, FDA Investigating, No Conclusive Link Determined, Voluntary Recall
Hyland's is issuing a voluntary recall of its Teething Tablets after some adverse affects were reported. The FDA is investigating, meanwhile the company has initiated a teething tablet product recall.
We initiated this voluntary recall to ensure our consumers know that their families' safety and health are our top priorities," said Mark Phillips, PharmD, President and Chief Pharmacist of Standard Homeopathic Company. "We are committed to maintaining and deserving the trust they have placed in Hyland's. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust."
The Hyland’s Teething Tablets UPC codes included in the recall are:
1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109
Hyland's Teething Tablets are sold over the counter at drug stores and pharmacy outlets throughout the USA.
Hyland's has set up a teething tablet recall website so consumers can get more information on the product recall.
Consumers that are concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall or call 1-877-496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).
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Female Genital Herpes (not verified)at 13:59 on October 26th, 2010
Any idea what adverse reactions were being experienced? I have found that general homeopathic remedies are well tolerated. Obviously, if you buy a remedy without having a full consultation with a qualified homeopath, there is a small risk that the product might not be right for you. Homeopathic remedies are prescribed, not only for the client's symptoms, but also according to the person's personality and temperament. However, general remedies are usually of low strength and are well tolerated. Of course another factor to bear in mind is that with homeopathy, the symptoms can get worse before they get better, and this does not necessarily mean that the product is doing you any harm. Shona
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Medgiver (not verified)at 12:08 on October 28th, 2010
So, I read the warning on the FDA site. What a bunch of bolognie. "Serious adverse events that are consistent with belladonna toxicity". Well, that means that the children's parents exceeded the recommended dosage. It has nothing to do with the tablets themselves--obviously, a 6 month old child cannot give themselves sublingual tablets. "Consumed more tablets than recommended because bottles don't have child-proof caps." Well, as with ANY OTHER MEDICATION, parents are supposed to keep these out of the reach of kids!! Is that the fault of the makers of these teething tablets? NO!! It is the fault of the parents who don't watch their kids!! The FDA is recalling the teething tablets because the reports that they received about this is only because of IRRESPONSIBLE PARENTS!!! Just about ANYTHING can cause harm to children---WATER can cause harm to children if they drink 10 gallons of it!! Is water recalled? NO! And, certainly, Tylenol/Motrin, which the FDA is now advising parents to give teething children, is VERY DANGEROUS!! They cause liver failure and toxicity!! Why doesn't the FDA come out and say that these meds are harmful to children? Why doesn't the FDA come out and say that too much formula can cause iron toxicity in babies? Because the ones who complained about this are the big pharmaceutical companies who are losing sales of their own over the counter analgesics because of this VERY EFFECTIVE medicine!! So, they try to come up with ANYTHING to get an herbal product recalled to increase their own sales!! It is a bunch of BULLSHIT!!! Furthermore, in the FDA's findings, they say that the tablets contain "inconsistent amounts of belladonna". Well, these teething tablets don't have to be FDA approved because they are herbal supplements. Where does the FDA come off doing something like this to sensationalize these VERY EFFECTIVE tablets? Hyland's should sue the FDA for defamation and slander. Belladonna toxicity is not from normal dosages of the tablets---it is from irresponsible parents giving their babies more than the recommended dosage!! The FDA and the media sensationalize shit like this, and scare the hell out of people for no good reason. It is a shame that something like this happened to a product that has shown to be wonderfully effective for over 85 years. No deaths have ever been reported from these teething tablets, and I am quite sure that the "children who consumed more tablets than recommended" are NOT children who are teething, but older children who decided to "sample" the pills in the medicine cabinet!! If irressponsible and lazy parents would keep an eye on their kids, stuff like this wouldn't happen. It is sad that babies and parents now have to suffer because of the actions of idiots like that. People should have to pass a licensing test to become parents, because the majority of them out there today are imbeciles.
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loving mother of 3 (not verified)at 13:46 on December 8th, 2010
i agree with you!!!! not the company's fault, it's the parents who don't follow the directions!!! my son has never had a problem and he felt so much better when he could use these, ugh damn fda
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Suzie (not verified)at 10:41 on October 30th, 2010
Here is word for word what I found on the recall website: 2. What exactly are the "adverse" effects referenced in the recall? Some children have been observed to show symptoms of fever, dry mouth, and drowsiness. FDA states adverse events have not been conclusively linked to Hyland's Teething Tablets. 5. Why is Standard Homeopathic Company/Hyland's recalling its Hyland's Teething Tablets? Hyland's is recalling its Teething Tablets in an abundance of caution after the company and the FDA conducted a thorough review of the company's adverse event reports and manufacturing processes. Together, we have identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. We also believe there are opportunities to refine the production, packaging and testing protocols on this product. 6. Is this recall related to the conversations around Belladonna overdosing concerns? No. With a sampling of our normal tablets an infant or child would need to take 1,025 of our Hyland's Teething Tablets to experience the first symptoms of dry mouth. If the Teething Tablet production process resulted in a variation of Belladonna, we are confident that children would still need to ingest significantly more than the dosing instructions on the label. We encourage you to continue to follow all label directions on over-the-counter medicines to ensure overdosing does not occur. 12. Why exactly are the Teething Tablets being recalled? The FDA has received adverse event reports they feel could possibly be related to Hyland's Teething Tablets. The evidence is non-conclusive. Because Hyland's cares about moms and babies more than anything else, being extra cautious, we are voluntarily recalling Hyland's Teething Tablets while we continue to investigate, refine and improve our manufacturing and testing process to continue to ensure safety for our consumer. 16. How will Hyland's remedy this situation? Hyland's is offering a coupon for a replacement Hyland's product or consumers can return their product for a refund. Complete details are provided by calling 1-877-496-5044 or at www.hylandsteething.com/recall.. 18. How do I return the product for a refund? Please mail the product to:Event #2265Stericycle4350 Sam Jones ExpresswayIndianapolis, IN 46241 Please include your name, address and phone number, so the refund can be sent to you. As we are processing a large number of requests, please allow up to 8 weeks to receive your refund. www.hylandsteething.com/recall/teething-tablet-recall-faq.html Hope this helps you!
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ms banana reality check retards (not verified)at 13:00 on November 20th, 2010
i think that giving babys pills is rediculiuos and to all those parents who fell for this bullshit ask ur self this if ur willing to medicater ur child this young are just gunna medicate them when they get older and have attitude?
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loving mother of 3 (not verified)at 13:44 on December 8th, 2010
are you crazy? It's like motrin or tylenol and it's very effective when the babies are suffering, it's not for a baby who is colicky, it's for TEETHING, and the ingredients relieve swelling, tenderness, irritability and pain. to each his own, if you don't like it, then you don't give it to your kids, if you even have any!!!!!!! it's not a damn narcotic!!!!!!!!!!!!!!! i feel awful for my 1 year old who is miserable when teething and if something helps HIM then i will do it. We didn't fall for "bullshit" cause the pills actually work!!!!!!!!!!!!!!!!!
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Charlize (not verified)at 18:10 on January 9th, 2011
I personally have found Hylands to be the best thing ever!! I recommend them to everyone. I am bummed they have been recalled as I used them for my 2 year old and found them to provide almost instant relief, I now have an 8 month old right in the thick of teething and he also responds well to these tabs, the sooner they are back on the shelves the better. www.gabandgossip.com