FDA Says Hyland Teething Tablets May Harm Children
October 26th, 2010 - 2:26 am ICT by Angela Kaye MasonOct 25 (THAINDIAN NEWS) Due to a possible risk to children, the FDA and Hyland’s Inc has announced a recall of Hyland’s Teething Tablets. According to the Food and Drug Association’s website, “FDA notified consumers that Hyland’s Teething Tablets is being recalled because the tablets may pose a risk to children. The tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna.”
The FDA goes on to explain that there have been reports of these tablets having adverse effects on children which were consistent with belladonna poisoning. There were also reports of children who had overdosed on the tablets because the bottle do not have a child safety cap.
According to the Hyland company’s website, “Adverse events have been reported but the FDA has said that a conclusive link has not been determined.” They go on to claim “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.”
Despite the claims form the company that their product is safe, the recall includes the following products:
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 6×125 tablets, UPC # 3 54973 35109
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Tags: adverse effects, adverse events, belladonna, child safety, clip strip, consumers, drug association, fda, food and drug, infants and toddlers, laboratory analysis, risk, safety cap, teething tablets, upc