Infants' Friend Pty Ltd in consultation with the Therapeutic Goods Administration is recalling all batches of Infants' Friend oral liquid due to the discovery of chloroform as an inactive ingredient.
The product is a registered complementary medicine used to relieve colic in infants from birth up to 12 months of age.
The recent TGA investigation discovered small amounts of chloroform as an inactive ingredient and when used at high doses, Infants' Friend oral liquid can expose children to unsafe levels of the organic compound.
However, intermittent, short-term use is not expected to be harmful.
At high doses or following long-term use, chloroform is known to cause damage to the liver, kidneys and nervous system.
The investigation found that the safety of Infants' Friend oral liquid was not acceptable due to the potential for infants to be exposed to unsafe levels of chloroform as the product did not specify a maximum number of doses or duration of use.
The TGA is considering further regulatory actions to ensure any future supply of this medicine meets high standards in safety, quality and effectiveness.
If you give Infants' Friend oral liquid to your child it is recommended that you discontinue using it.
If you have any Infants' Friend oral liquid, the remaining product can be returned to the place of purchase for a refund.
If you have any questions or concerns about this issue, talk to your health professional or contact Infants' Friend Pty Ltd customer service on 1800 981 403.
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