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Hyland's Teething Tablet Product Recall Information - Cananda
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HYLAND’S TEETHING TABLETS PRODUCT RECALL SUMMARY FAQ’s
PRODUCT & YOUR CHILD'S SAFETY
RECALL DETAILS AND WHAT TO DO NOW
PRODUCT INGREDIENTS
HYLAND'S & YOUR TRUST
SUMMARY FAQ’s 1. Has Standard Homeopathic Company/Hyland’s Canada recalled all Hyland’s Teething Tablets? Yes. Hyland’s Canada is recalling all Teething Tablets. This includes all Lot numbers. 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. 3. When will Hyland’s Teething Tablets be back on the market? That's difficult to say. We believe this is an opportunity to build in additional improvements to the product and process. Our child resistant cap is developed and ready to implement. We have already begun the process and will keep you posted as to when you can expect Hyland's Teething Tablets back on store shelves. 4. What can I give my child to relieve teething pain? Hyland's Teething Gel is a great alternative for easing your child's teething pain, and is not affected by the recall in any way. Hyland's homeopathic Teething Gel is different from other teething gels on the market because it contains no numbing benzocaine or any added parabens, artificial flavors or dyes. 5. Why is Standard Homeopathic Company/Hyland's Canada recalling its Hyland's Teething Tablets? Hyland's Canada 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. 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. PRODUCT & YOUR CHILD'S SAFETY After in-depth analysis, a comprehensive review of the company's adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland's Teething Tablets are safe for infants and toddlers. Adverse events have been reported but the FDA has said that a conclusive link has not been determined. 8. Should I be worried about any adverse events if my child has recently used Hyland's Teething Tablets? There is no conclusive evidence that the Teething Tablets are harmful. We have initiated this recall because we do not want parents to bear any concerns or doubts in easing their child's pain with Hyland's Teething Tablets. We feel that this is the right decision to reassure our consumers of our commitment to absolute safety. 9. I've sometimes noticed that when I give my child Hyland's Teething Tablets, s/he falls instantly asleep? Should I be concerned? No. Hyland's Teething Tablets often provide welcome relief to an infant suffering from teething pain. That pain often prevents much needed sleep so when that pain is relieved, the child often will fall asleep, pain-free. 10. Are there any long-term effects? I have given Hyland's Teething Tablets to my child in the past. No. Any potential adverse effects associated with this product would occur soon after use. Again, there have been no adverse effects conclusively linked to Hyland's Teething Tablets. We are confident that they are and have been safe for use. 11. Are you doing anything to prevent the bottles being opened by children? We have already developed child-resistant caps for Hyland's Teething Tablets bottles. As we work on the product for re-launch, we expect to have child-resistant caps on all bottles of Hyland's Teething Tablets. RECALL DETAILS AND WHAT TO DO NOW 12. Why exactly are the Teething Tablets being recalled? The U.S. Food and Drug Administration (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. 13. What Hyland's Teething Tablets are involved in this recall? All Hyland's Teething Tablets are included in the recall. 14. What are the manufacturing dates covered in the recall? All Hyland's Teething Tablets are included in the recall. 15. How did Hyland's become aware of the problem? Homeopathic medicines are regulated by the FDA and subject to regular inspections of facilities. In the course of our most recent inspection, the company and the FDA identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity of dosage. 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 1.800.363.8933 or at www.hylandsteething.com/recall/ca. 17. What should I do with product in my possession? If you are concerned about the safety of the product, you can call 1.800.363.8933 or go to www.hylandsteething.com/recall/ca for more information on how to receive a coupon for a replacement Hyland's product or for instructions on how to return the product for a refund. 18. How do I return the product for a refund?
Please mail the product to: 19. It seems a hassle to have to send the product in to get a refund. Why do I have to do this? In order to help us improve our manufacturing process, we need to have the product returned. We know this is a hassle, but will be sending a reimbursement that includes a shipping allowance. We thank you in advance for your inconvenience. 20. Where do I find the DIN and lot number to apply for a refund or replacement coupon? It is the same DIN number for all the products: 01956485. You can find th DIN and lot number on the carton and bottle label. The DIN number is found directly above the Hyland's logo. The lot number is imprinted on the far right hand side of the label. You will also find these numbers on the carton, if you have kept the outer packaging. It is also imprinted (but perhaps harder to read) on the flap of the right hand side panel. 21. What Hyland's products can be purchased if I opt for the coupon? The coupon can be used for any Hyland's product on the market, up to a $14.99 retail value. 22. Has Hyland's Canada notified the appropriate authorities? Yes. Hyland's Canada has notified and worked with Health Canada. PRODUCT INGREDIENTS 23. What are the ingredients in the Teething Tablets and which ones are the FDA concerned about? Hyland’s Teething Tablets contain: Calcarea Phosphorica 3X HPUS, Chamomilla 3X HPUS, Coffea Cruda 3X HPUS, and Belladonna 3X HPUS. (The initials HPUS indicate that these ingredients are included in the Homeopathic Pharmacopeia of the US.) FDA's advisory expresses concerns regarding Belladonna. For complete safety profile information on Hyland's Teething Tablets and Belladonna, go to www.hylandsteething.com/recall/belladonna-safety-info.html. 24. What exactly is Belladonna and what is its purpose in the Teething Tablets? Belladonna is a plant and in its homeopathic preparation is included in Hyland's Teething Tablets to treat redness and inflammation. 25. Is there too much Belladonna in certain tablets? Hyland's Teething Tablets are safe. 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. HYLAND's CANADA & YOUR TRUST 26. I'm disappointed by this recall. We've trusted Hyland's Canada for years. What do you want to be saying to us? Hyland's Canada is committed to your health and safety, and especially that of our youngest consumers. We have earned your trust for over 100 years by providing safe and effective homeopathic medicines. We intend to maintain that trust and continue to partner with you to provide solutions for your family's health…naturally. This recall is an example of how seriously we take this charge and we will do everything we can to ensure we don’t disappoint you again. 27. Should we be concerned about Hyland's products? Not at all. You have no reason to be concerned about any of our products. Homeopathic products offer consumers a wide margin of safety with their use and we remain committed to providing our families the highest quality products. 28. Has Hyland's ever had a recall before? Standard Homeopathic Company, which owns and manufactures the Hyland's brand of products, has never had a product recall in over 100 years of manufacturing homeopathic medicines. 29. Can I speak directly to someone at Hyland's Canada? Live call-in agents are available to take your call at 1-800-363.8933 . At this time, they are available Monday through Friday, 9 a.m. to 5 p.m. ET. We are returning calls if you provide your information. In the meantime, we continue to have a pharmacist available 24/7 to return your call to provide information regarding any concerns you may have regarding Hyland’s Teething Tablets. Hyland’s pharmacist can be reached by calling 1-800-624-9659. |
