Drug regulator clears Benylin Paediatric syrup after nationwide recall

The South African Health Products Regulatory Authority has conducted independent testing of the two affected batches and found no trace of the toxin, reported in five other African countries.

The South African Health Products Regulatory Authority (Sahpra) has given Benylin Paediatric syrup the all-clear after its testing found no traces of diethylene glycol in the product.

In April, the authority issued a country-wide Class 1 Type A recall of Benylin, indicating it had a severe product quality concern that could have dire consequences. 

Urging the public not to panic, it said it was dealing with the matter urgently and that batch recalls were batch-specific.

“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.”

They recalled Benylin Paediatric as a precautionary measure over reports that five African countries — Nigeria, Kenya, Rwanda, Eswatini and Tanzania — had issued recalls after high levels of the contaminant were found in the syrup, which is indicated for cough relief in children. 

Nigeria was the first country to flag the contamination: On 10 April, Bloomberg reported that Nigeria’s health ministry had recalled a batch of the J&J Benylin Paediatric syrup, over an “unacceptable high level of diethylene glycol (that) was found to cause acute oral toxicity in laboratory animals”, the Food and Drug Administration and Control said in a public alert.

The affected batches were produced in South Africa in 2021 and were set to expire in April, the Nigerian regulator said.

Diethylene glycol is toxic to humans. Consumption can result in abdominal pain, vomiting, diarrhoea and acute kidney injury, which may lead to death.

At the time, Daily Maverick contacted Johnson & Johnson, which still manufactured Benylin Paediatric in 2021, and its spokesperson Clare Boyle insisted that it was no longer a J&J product.

“It is a product sold by Kenvue,” she said. 

Kenvue, which was previously J&J’s consumer healthcare division, now owns the Band-Aid, Listerine, Neutrogena and other brands.

Despite not being responsible for the seemingly tainted batches, Kenvue is believed to have conducted its own testing of the affected batches, which cleared the product. It was awaiting clearance from the various authorities.

A Kenvue spokesperson told Daily Maverick that they welcomed Sahpra’s statement reaffirming the safety of the batches of Benylin Paediatric Syrup.

“Using the testing method recommended by the World Health Organization, Sahpra independently tested the relevant batches. Kenvue also tested the batches 329303 and 329304 using the WHO-recommended method. Both these tests found no presence of diethylene glycol (DEG) or ethylene glycol (EG). There were no adverse events reported for batches 329303 and 329304.”

Kenvue said they followed strict and robust safety and quality processes to ensure that consumers could trust their products and stand by the safety of the Benylin range.

 On Wednesday, Sahpra said it had tested samples of the two affected batches of Benylin Paediatric syrup in an independent laboratory using a method developed by the World Health Organization for testing products for the presence of diethylene glycol. 

“The tests did not find traces of diethylene glycol in the recalled batches. This indicates that units of batches 329303 and 329304 that were stored at the required temperature would not contain unacceptable levels of diethylene glycol.” 

Sahpra said there was furthermore no record of any adverse drug reactions relating to diethylene glycol for the two recalled batches in South Africa “or anywhere else” where they were exported to on the continent.

Sahpra CEO Dr Boitumelo Semete-Makokotlela said the authority would continue to closely monitor medical products that had the potential of containing unacceptable levels of diethylene glycol. 

“And we will continue to address safety concerns or quality issues so that the health of the public is protected.”