Urgent medical recall - Infants' Friend Oral Liquid Bottle 100mL
December 24, 2020
Infants' Friend Pty Ltd is recalling all batches within expiry of their Infants' Friend Oral Liquid 100mL.
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.