Homeopathic baby products recalled following labelling failure
The TGA has announced a recall of all batches of Hyland’s Baby teething tablets and Hyland’s Baby nighttime teething tablets.
The recall, announced by the TGA in conjunction with manufacturer Kadac, is being undertaken following an investigation by the US Food and Drug Administration.
It found products supplied in the US contained inconsistent amounts of belladonna alkaloids, a toxic substance, which may differ from the calculated amounts listed on the products’ labels.
While the TGA had tested samples of these products supplied in Australia and found no quality issues, Kadac is now recalling the tablets as a precautionary measure due to the potential safety risk that belladonna alkaloids can pose to children.
The effects of belladonna can be unpredictable and could cause serious health problems.
Hyland’s homeopathic teething tablets are complementary medicines marketed to provide temporary relief of teething symptoms in children.
Hyland’s Baby teething gel is not affected by this recall. However, all Hyland’s baby teething products, including the gel, will no longer be marketed in Australia.
Consumers are being advised to not use any Hyland’s Baby teething tablets or Hyland’s Baby nighttime teething tablets and to return them to the place of purchase for a refund or to call Kadac on 1300 762 025.
Health professionals are advised to be “aware of this issue and advise patients accordingly if they seek advice”.
Hyland’s released a statement following the US recall, saying it had made the decision to recall in response to a request from the FDA and that “all manufactured and sold teething medicines met the Company’s safety limit tests and all tested product has been well within an established safety threshold”.
Calls to Kadac’s office went unanswered on Saturday, according to Fairfax media sources.
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