The South African Health Products Regulatory Authority (SAHPRA) has recalled two batches of Benylin Paediatric Syrup.
A spokesperson Madimetja Mashishi says on the 10th of April they received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding the detection of high levels of diethylene glycol in a bach of the syrup.
He says the public should not panic as the matter is being addressed as a priority.
SAHPRA also engaged with the South African manufacturer and decided to recall the batches as it was in the public's best interest.
He says two batch numbers have been recalled and healthcare professionals have been instructed to remove them from their shelves.
The affected batch numbers are 329304 and 329303. These affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
Classification of the recalls
The recall is classified as a Class 1, Type A recall, associated with a serious product quality concern that may have severe consequences. This is a country-wide recall.
The product is recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
What the public should know
Diethylene glycol is toxic to humans when consumed and can prove fatal.
Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death.
Members of the public who have consumed these two batches and experienced any adverse reaction or witnessed it in children should consult their healthcare professional and report this using the Med Safety App or send an email to: adr@sahpra.org.za.
