Urgent recall – Infant’s Friend Oral Liquid Bottle 100mL
An urgent recall has been made for Infant’s Friend Oral Liquid Bottle 100mL – all batches within expiry since December 2018 (Reference RC-2020-RN-01350-1).
The amount of the excipient trichloromethane (chloroform) contained within Infants’ Friend Oral Liquid exceeds the Tolerable Daily Intake (TDI) at the recommended dose.
Following an investigation, it was 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.
At high doses and/or following long-term use, chloroform is known to cause damage to the liver, kidneys and nervous system. However, intermittent, short-term use is not expected to be harmful.