viernes, 14 de abril de 2017

FDA announces Standard Homeopathic Company’s nationwide voluntary recall of Hyland’s teething tablets - Drug Information Update

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

FDA is alerting consumers of a nationwide voluntary recall of all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets by the manufacturer, Standard Homeopathic Company, which is located in Los Angeles. On April 10, the company received FDA’s formal recall request and agreed to conduct a recall.
Standard Homeopathic Company is notifying its distributors and retailers by mail and is arranging for the return of all recalled products.  Consumers who have products which are being recalled should contact the company.
Consumers with questions regarding this recall can contact Standard Homeopathic Company by calling 1-800-991-3376 (Monday-Friday 6 a.m. to 4 p.m. Pacific Time).  Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to taking or using this drug product.
FDA reminds consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.
On January 27, 2017, FDA announced its laboratory analysis had found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets including Hyland’s, sometimes far exceeding the amount claimed on the label. In light of these findings and prior to the announcement, FDA contacted Standard Homeopathic Company on January 25 regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna.
FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething products to the FDA’s MedWatch Adverse Event Reporting program:
To view the full FDA communication, please visit: Hyland's Teething Tablets.

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