By Ncaba Ntshakala
The Ministry of Health has issued an alert regarding the recall of two batches of Benylin Paediatric Syrup, manufactured by Kenvue (formerly Johnson and Johnson) after they were found to contain high levels of diethylene glycol, a toxic chemical.
The recall was initiated by the South African Health Products Regulatory Authority (SAHPRA) and other National Regulatory Authorities in Africa.
According to the statement issued by the Minister of Health Mduduzi Matsebula, the affected batches, numbered 329304 and 329303, were produced in May 2021 and have expiry dates in April 2024.
Diethylene glycol, a highly toxic substance, can lead to severe health complications when ingested, including abdominal pain, vomiting, diarrhoea, headaches, altered mental state, and acute kidney injury, which may prove fatal.
In response to this alarming discovery, SAHPRA has mandated the immediate recall of the affected batches while investigations are ongoing.
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Benylin Paediatric Syrup, a bright red syrup with a fruity raspberry odour, is commonly used for the relief of cough and congestive symptoms, as well as for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.
The Ministry of Health has been informed by SAHPRA that 144 units of batch 329303 were distributed to Eswatini’s private market on 15 June 2021, with no availability in Government facilities.
The Ministry expressed that it is actively engaging with private healthcare facilities to determine the extent of distribution of these units.
Additionally, preparations are underway for the discontinuation of prescribing and use of the affected batch and the recall of any remaining units in the market.
The Ministry further strongly advise the public to check the batch numbers of any Benylin Paediatric Syrup they possess.
“If any of the mentioned batch numbers are found, individuals are urged to discontinue use immediately.” Reads the statement.
“Those who have ingested the syrup and are experiencing symptoms are advised to seek medical attention at the nearest health facility.
Identified syrups should be returned to the dispensing facility, and individuals can contact the Medicines Regulatory Unit of the Ministry of Health on the WhatsApp number 7655 7303 for further assistance.”
The Ministry also reassured the public that it will provide updates on any developments regarding the matter.
Syrup has been recalled in six African nations
The South African Health Products Regulatory Authority (SAHPRA) together with the South African manufacturer of Benylin Paediatric Syrup, Kenvue (formerly Johnson & Johnson) recalled two batches of the cough medication, in six African countries, after laboratory findings in Nigeria showed potentially deadly levels of toxicity. The countries are South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
In a statement released on Saturday night, SAHPRA CEO Boitumelo Semete-Makokotlela said the recall of medical products was a crucial measure taken by the national regulatory authority to address safety concerns or quality issues to protect public health.
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“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,” she said.
SAHPRA said it received a report from Nigeria’s National Agency for Food and Drug Administration and Control (Nafdac) on April 10 regarding the detection of high levels of diethylene glycol in a batch of Benylin Paediatric Syrup.
As a result, SAHPRA immediately contacted the South African manufacturer Kenvue for a response, and it was then resolved that affected batches would immediately be recalled in the best interest of the public while an investigation was ongoing.
