South Africa and J&J has become entangled in one of the world's worst wave of poisoning from oral medication with the recall of a locally manufactured Johnson & Johnson (J&J) cough syrup for children, writes MedicalBrief.
Days after J&J attempted to distance itself from another high-profile scandal linked to its products, the South African Health Products Regulatory Authority (SAHPRA) issued a recall of two batches of Benylin Paediatric cough syrup due to contamination of a toxic compound better known in the production of coolants for engines, wallpaper strippers, inks, and other industrial products, the Daily Maverick reports.
Such products are required to be clearly labelled “harmful, if swallowed”.
Diethylene glycol (DEG) is toxic to humans when consumed and can be fatal. Consumption can result in abdominal pain, vomiting, diarrhoea and acute kidney injury, which may lead to death.
On Thursday, Bloomberg reported that Nigeria’s Health Ministry had recalled a batch of J&J’s Benylin Paediatric syrup, which is also used to treat hay fever and other allergic conditions in children under the age of 12, because it contained an “unacceptable high level of diethylene glycol and 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 – described as “substandard” – were produced in South Africa in 2021 and were set to expire this month, the Nigerian regulator said.
On Saturday, 13 April, five more countries, including South Africa, recalled the cough syrup, which was produced by J&J.
While the multinational pharmaceutical company no longer produces Benylin, the affected batches were in fact manufactured by it in 2021.
J&J spokesperson Clare Boyle insisted that “on the record”, Benylin Paediatric was not a J&J product. “It is a product sold by Kenvue.”
When challenged about the affected batch, which was manufactured while J&J still owned the Benylin brand, Boyle failed to respond.
Kenvue said in a statement that it takes this matter “very seriously”, and is acting with urgency to conduct a thorough safety and quality assessment.
SAHPRA has alerted healthcare professionals and the public to discontinue the use of the two batches, remove them from their inventory and return them.
Those who have consumed these affected products should consult their healthcare professional.
On 4 April, The New York Times reported that J&J had reached an $8.9bn (R167bn) settlement over its talcum powder case. The pharmaceutical group has been investigated in the US by more than 40 states, after thousands of lawsuits alleged it failed to warn customers about cancer risks.
Drug regulators in Tanzania, Rwanda and Zimbabwe have recalled a batch the J&J cough syrup as a precautionary measure after their Nigerian counterpart said laboratory tests found high levels of toxicity, and after Kenya, and then South Africa this week, also recalled batches of the medicine.
In a statement, SAHPRA urged the public not to panic as the matter was being handled with priority. "Batch recalls are batch-specific and do not necessarily apply to other batches/similar products. 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."
Laboratory tests on the syrup by Nigeria’s health regulator showed a high level of diethylene glycol, which has been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon since 2022.
The batch of Benylin Paediatric syrup recalled was made by J&J in SA in May 2021, though Kenvue now owns the brand after a spin-off from J&J last year.
Tanzania Medicines and Medical Devices Authority (TMDA) said it had begun the recall on 12 April after hearing about the Nigerian test results.
“This is an exercise that does not involve investigation but rather monitoring to ensure the affected drugs are removed from the market,” said TMDA spokesperson Gaudensia Simwanza.
“A review of our safety database doesn’t reveal any adverse events reported,” the Rwanda Food and Drugs Authority said in a statement. “However, Rwanda FDA issues the present recall for precautionary measures.”
Zimbabwe’s Medicines Control Agency said that it had a record of the product’s importation into Zimbabwe, but it was concerned the syrup could enter the local market illegally. It said it would step up inspections.
SA pulls product
Sahpra said the countrywide recall of the product is classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences.
The medicine is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
The two affected batch numbers are 329304 and 329303, and were distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
SAHPRA said this type of recall is batch-specific and does not necessarily apply to other batches/similar products.
Reuters article – Tanzania, Rwanda, Zimbabwe join African recall of J&J cough syrup (Open access)
Daily Maverick – Benylin Paediatric cough syrup recalled in six countries due to toxic compound
Reuters article – Nigeria recalls J&J cough syrup made in SA over toxic substance (Open access)
Reuters article – Kenya recalls J&J children's cough syrup over suspected toxicity (Open access)
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