The South African Health Products Regulatory Authority (SAHPRA) has recalled two batches of Benylin Paediatric Syrup, after high levels of diethylene glycol were detected in a batch of the Syrup.
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.
The authority said the syrups are from the affected products come from batches 329303 and 329304.
“The South African Health Products Regulatory Authority (SAHPRA) 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 batch of Benylin Paediatric Syrup.
“SAHPRA immediately contacted the South African manufacturer, Kenvue (formerly Johnson and 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 is ongoing,” said SAHPRA spokesperson, Madimetja Mashishi.
The syrup is meant 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.
These affected batches have been distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria.
The regulator urged the public not to panic and confuse the recalled products with others.
“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-licenced 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,” explained Mashishi.
SAHPRA highlighted that the recall is country-wide, from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
The authority has urged members of the public who have consumed these two batches and experience any adverse reaction or witness it in children, to immediately seek medical attention.
