Consumers and health professionals are advised that Care Pharmaceuticals Pty Ltd, in consultation with the TGA, is recalling 10 batches of Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets due to the presence of Carthamus tinctorius flower (safflower flower) as an inactive ingredient. The level of exposure of Carthamus tinctorius flower in this product poses an unacceptable risk if used in pregnancy.
The recall affects all batches within the current expiry date (10 batches in total).
The affected batch numbers are:
Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets is a listed complementary medicine (AUST L 288102) used to relieve the symptoms of dehydration.
The TGA recently became aware that Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets includes Carthamus tinctorius flower as an inactive ingredient. The level of exposure of Carthamus tinctorius flower in this product poses an unacceptable risk if used in pregnancy.
The TGA investigation concluded that the safety of Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets was unacceptable as it may expose consumers to Carthamus tinctorius flower during pregnancy. Further, the product does not contain the mandatory label warning ‘Do not use if pregnant or likely to become pregnant' due to the inclusion of Carthamus tinctorius flower as an inactive ingredient. This issue does not affect any other Hydralyte flavours or products.
Information for consumers
Please be aware that Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets pose an unacceptable risk if used during pregnancy.
You should stop using this medicine if you are pregnant or if becoming pregnant is a possibility. If you have any of the affected batch numbers of the medicine detailed above, the remaining product can be returned to the place of purchase for a refund.
If you have any concerns or questions about this issue, speak to your health professional or contact Care Pharmaceuticals Pty Ltd customer service on 1800 788 870.
Information for health professionals
Please be aware of the above issue and advise patients accordingly if they seek advice.
If you have any questions or concerns about this issue, contact Care Pharmaceuticals Pty Ltd on 1800 788 870.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.