CONSUMER RECALL NOTICE
This recall is being conducted as a precaution because of the TGA’s concern about the presence of chloroform in the product and there being no maximum dosage listed on the bottle’s labelling. Intermittent, short-term use of the product is not expected to be harmful (which is generally the case when using this product for the symptomatic relief of colic, wind or teething discomfort).
The risks associated with the product would only appear if you are administering large amounts of the product over an extended period of time (ie administering the product at the maximum doses, multiple times per day and continuously over a long period). Usage in this way would be extremely unlikely for a product that is intended for the relief of acute symptoms and the use of which will cease once symptoms subside.
Chloroform is not listed on the bottle as it is an excipient, meaning it doesn’t have any influence over the product’s efficacy. This excipient is used to aid the manufacturing process of dissolving the active ingredients (essential oils) in to the product’s purified water base. Only active ingredients are listed on the label in accordance with the TGA’s labelling guidelines. The presence of chloroform in the product is stated in the ARTG Public Summary for the product, which is a public database available on the TGA’s website.
The company has agreed to recall product because the TGA has safety concerns regarding the content of chloroform in the product.
The product contains 74 micrograms of chloroform per mL of oral liquid, or put another way, 0.007mL of chloroform in a 100mL bottle.
The directions for use currently do not stipulate a maximum daily dose as the dosage instructions refer to: “Can be given before or after each feed and if necessary between feeds” This therefore means that the product could potentially be used an unknown number of times, and therefore the maximum daily intake of chloroform cannot be conclusively determined to be within safe and acceptable limits.
The product is intended for use in infants from birth up to 12 months of age for symptomatic relief of colic and wind, restlessness and irritation during teething and to keep bowels regular. It is intended for short term-intermittent administration only for these acute conditions.
The likelihood that an infant would be exposed to levels of chloroform that might be harmful resulting in acute toxicity is very low as evidenced by the scarcity of adverse events reported in the past 85 years that the product has been supplied.
The likelihood of long-term toxic effects including carcinogenicity is also very low, as the product is intended only for the acute relief of specific symptoms, being colic, wind and teething. The product is not intended to be used, nor is it likely to be used, consecutively over a long period of time.