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Infants' Friend oral liquid

Recall due to presence of chloroform

23 December 2020

Consumers and health professionals are advised that Infants' Friend Pty Ltd, in consultation with the TGA, is recalling all batches of Infants' Friend oral liquid due to the presence of chloroform as an inactive ingredient.

Infants' Friend oral liquid is a registered complementary medicine (AUST R 26678) used to relieve colic, during teething and to keep bowels regular. It is labelled for use in infants from birth up to one year of age.

The TGA recently became aware that Infants' Friend oral liquid includes a small amount of chloroform as an inactive ingredient. When used at high doses, Infants' Friend oral liquid can expose children to levels of chloroform that are higher than the level established to be safe. However, intermittent, short-term use is not expected to be harmful.

The TGA investigation concluded that the safety of Infants' Friend oral liquid was not acceptable due to the potential for infants to be exposed to intakes of chloroform that exceed a safe level. This conclusion took into consideration that the product label did not specify a maximum number of doses or duration of use, which may lead to prolonged use at high doses. The TGA’s main concern is when multiple doses are taken on a daily basis for months.

Consumers are advised to talk to their health professional with any concerns.

At high doses and/or following long-term use, chloroform is known to cause damage to the liver, kidneys and nervous system. The established safe level of intake for chloroform is based on studies in animals and include wide safety margins.

Infants' Friend oral liquid is a 'grandfathered' medicine, which means that it was available in Australia prior to 1990. As a grandfathered medicine, the TGA has not evaluated Infants' Friend oral liquid for safety, quality or effectiveness. Further regulatory actions are being considered to ensure any future supply of this medicine meets the TGA's high standards for safety, quality and effectiveness.

Information for consumers

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.

If you suspect your infant has had an adverse effect to this product, please report it to the TGA.

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 Infants' Friend Pty Ltd on 1800 981 403.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

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.