POLOKWANE – The South African Health Products Regulatory Authority (Sahpra) has recalled two batches of Benylin pediatric cough syrup.

Last week, the Nigerian National Agency for Food and Drug Administration and Control reported that a batch of Benylin paediatric cough syrup had high levels of diethylene glycol detected in it.

Sahpra states that diethylene glycol is toxic to humans when consumed and can prove fatal.

“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury that may lead to death,” their statement reads.

Sahpra immediately contacted the South African manufacturer, Kenvue  (formerly Johnson and Johnson) for a response and 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.

Sahpra, in collaboration with Kenvue, has identified the affected batch numbers as 329304 and 329303 which have been distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.

“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that they protect the health of the public. We are recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events,” Sahpra CEO Dr Boitumelo Semete-Makokotlela said.

Benylin paediatric is a bright red syrup with a raspberry smell and taste, packaged in a 100ml amber glass bottle with a plastic measuring cup.

It is used to relieve cough and congestive symptoms and treat hay fever and other allergies affecting the upper respiratory tract.

Semete-Makokotlela has urged 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 or similar products. The manufacturer is a Sahpra-licenced manufacturer and complies with Good Manufacturing Practices,” said Semete-Makokotlela.

The drug watchdog stressed that the recall is limited to two batches and that the public 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 channels immediately,” she said.

The recall is classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences.

Sahpra added that the recall is countrywide and affects hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.

Those 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.