Two batches of Benylin Paediatric Syrup have been recalled by the South African Health Products Regulatory Authority (SAHPRA) following discussions with the manufacturer.
The health products regulatory body said that on April 10, they received a report from the Nigerian National Agency for Food and Drug Administration and Control about the high levels of diethylane glycol in a batch of Benylin Paediatric Syrup.
Diethylene gylcol is toxic to humans when consumed and can prove to be fatal, SAHPRA CEO, Boitumelo Semete-Makokotlele, said.
“Toxic affects can include abdominal pain, vomiting, diarrhoea, inability to pass urine altered mental state, headaches and an acute kidney injury which may lead to death,” Semete-Makokotlele said.
SAHPRA immediately got in contact with the South African manufacturer Kenvue.
“Following engagements with the manufacturer and the best interest of the public, it was resolved that the affected batches would be immediately recalled while an investigation is ongoing,” SAHPRA said.
Semete-Makokotlele said that SAHPRA has recalled batches 329304 and 329303 both expiring in April 2024 while it conducts an investigation.
The affected batches have been distributed to the South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
According to SAHPRA, the recall is a Class 1, Type A recall. This type of recall is associated with a serious product quality concern that may have serious consequences.
The recall is country-wide which means that the product is being recalled form hospitals, retail outlets. healthcare professional, authorised prescribers, individual customers and patients.
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📢[READ] Media Release - https://t.co/BK15iISxZF#SAHPRA#productrecall#Benylin
The Benylin Paediatric Syrup is a clear bright read syrup that smells and tastes like raspberries. It is packaged in a amber glass bottle that has 100ml of syrup and a plastic measuring cup.
The syrup is used to treat coughs and its cognitive symptoms and for the treatment of hay fever as well as other allergic conditions that affect the upper respiratory tract.
SAHPRA has asked the public not panic and said that the matter is being handled as a priority.
The regulatory body said that the recall is limited to two batches and that the public should not panic regarding the range of products bearing the same name.
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