FDA

Child Safety – FDA Product Recall Notice: Hyland’s Teething Tablets

The information below is directly from the FDA press release regarding the voluntary recall of Hyland’s Teething Tablets. FOR IMMEDIATE RELEASELos Angeles, October 23, 2010 – Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America. The Hyland’s Teething Tablets UPC codes included in the recall are: Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041 Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042 Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066 Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044 Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121 Hyland’s Teething Tablets, Clip Strip 6×125 tablets, UPC # 3 54973 35109 Adverse events have been reported but the FDA has said that a conclusive link to Teething Tablets has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm. 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. In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with […]

By |October 26th, 2010|Info, Safety|0 Comments

Infant Safety: Deaths prompt CPSC, FDA warning on infant sleep positioners

The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) today warned consumers to stop using infant sleep positioners.  Over the past 13 years, CPSC and the FDA have received 12 reports of infants between the ages of 1 month and 4 four months who died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet. Most of the infants suffocated after rolling from a side position to a stomach position. In addition to the reported deaths, the government has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners. The two main types of infant sleep positioners are flat mats with side bolsters or inclined mats with side bolsters. Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of sudden infant death syndrome, or SIDS, but the Food and Drug Administration has never approved these products as safe. And the government said it was unaware of any scientific studies demonstrating that infant positioners prevented death or were proven to prevent suffocation or other life-threatening harm. For more information regarding this warning please visit the CPSC website.

By |September 29th, 2010|Info, Safety|0 Comments
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