US/Silver Spring: Standard Homeopathic Company recalls certain batch/lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets due to suspected inconsistent amounts of Belladonna Alkaloids, a serious health hazard. FDA: http://ht.ly/SWbN30aSox5
Direct link: https://www.fda.gov/Safety/Recalls/ucm552934.htm
The US Food and Drug Administration (“FDA”) reports the following drugs are subject to this recall:
- Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets, sold to provide temporary relief of teething symptoms in children. Although Standard Homeopathic Co. stopped manufacturing and shipping these drugs US nationwide in October 2016, this recall includes all remaining products that retailers may have had in stock.
Please consult the photograph above for details of the drug’s packaging, design and retail presentation.
==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.
According to the FDA, there is no known safe dose or toxic dose of Belladonna in children because of the many factors that affect it. The FDA, therefore, believes that Belladonna represents a serious health hazard to children and that the effects of Belladonna are unpredictable.
If you believe you have purchased or have in your possession any of the recalled drugs, please do not consume them directly nor use them as an ingredient in another medicinal preparation. Instead, return the drugs to the store where you purchased it for a full refund.
If you have any questions about this recall, please contact Standard Homeopathic Company at 1-800-991-3376 from 6:00 AM to 4:00 PM Pacific Standard Time.
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More information about this recall:
Recalls Direct RIN: 8543-2017
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Filed under: Anaphylaxis, Children, Drugs, Labeling or regulatory issues, Medical / Veterinary, US FDA | Tagged: Anaphylaxis, children, drug, FDA, Homeopathic drug, Hyland’s Baby Nighttime Teething Tablets, Hyland’s Baby Teething Tablets, infants, Recalls Direct RIN: 8543-2017, Standard Homeopathic Company, US Food and Drug Administration |