Benylin Paediatric Syrup recall
THE SA Health Products Regulatory Authority (Sahpra) has recalled two batches of Benylin Paediatric Syrup following the detection of high levels of diethylene glycol.
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.
Sahpra said it had received a report from the Nigerian National Agency for Food and Drug Administration and Control regarding the detection, and then immediately contacted South African manufacturer, Kenvue (formerly Johnson & Johnson) for a response.
Following engagements with the manufacturer and in the best interest of the public, it was resolved that affected batches would immediately be recalled while an investigation was ongoing.
“Sahpra, in collaboration with Kenvue, have identified the affected batch numbers as 329304 and 329303. These affected batches have been distributed to the following countries: South Africa, eSwatini, Rwanda, Kenya, Tanzania and Nigeria,” it said.
Benylin Paediatric presents as a clear, bright red syrup having a raspberry odour and taste, packed in amber glass bottles containing 100ml with a plastic measuring cup.
It is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.
“Sahpra wishes to inform the public not to panic as the matter is being handled with priority. Batch recalls are batch-specific and do not necessarily apply to other batches/ similar products. The manufacturer is a Sahpra-licensed manufacturer and complies with good manufacturing practices.
“The public is reminded that the recall is limited to two batches and should not panic regarding the range of products bearing the same name. “Sahpra is alerting healthcare professionals and the public to discontinue the use of the two batches mentioned, remove them from their inventory and return them to their normal distribution channel(s) with immediate effect.”
Sahpra CEO Dr Boitumelo Semete-Makokotlela said: “As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public.
“Sahpra is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events.”
Members of the public who have consumed from the two batches who experience any adverse reaction or witness it in children should consult their healthcare professional.
They are also advised to report this using the Med Safety App or send an email to: adr@sahpra.org.za