The authority said it alerted healthcare professionals and the public to “discontinue the use of the two batches, remove them from their inventory and return them to their distribution channels with immediate effect”.
This is a class 1 recall, which means the product is linked to “a serious product quality concern that may have severe consequences”.
The affected batches have been recalled from hospitals, retailers and authorised prescribers, among others.
Sahpra CEO Dr Boitumelo Semete-Makokotlela said: “As a national regulatory authority the recalling of medical products is a crucial measure to address safety concerns or quality issues so we protect the health of the public.”
“Sahpra is recalling these two batches because of reported high levels of diethylene glycol with the potential to cause serious adverse events.”
Diethylene glycol is toxic to humans and can prove lethal, according to Sahpra.
Its effects include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state and acute kidney injury which may lead to death.
TimesLIVE
Benylin cough syrup batches recalled after discovery of toxic compound
Image: 123rf
The South African Health Products Regulatory Authority (Sahpra) has issued a countrywide recall of two batches of Benylin paediatric syrup after they were found to have high levels of toxic diethylene glycol.
The authority was alerted to the issue on Wednesday by the Nigerian National Agency for Food and Drug Administration and Control.
After engagements with the South African manufacturer, Kenvue (formerly Johnson and Johnson), Sahpra said it was resolved that the affected batches would immediately be recalled pending an investigation.
The recalled batches have been identified as 329304 and 329303 and have been distributed in South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
“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-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.”
Kenya recalls J&J children's cough syrup over suspected toxicity
The authority said it alerted healthcare professionals and the public to “discontinue the use of the two batches, remove them from their inventory and return them to their distribution channels with immediate effect”.
This is a class 1 recall, which means the product is linked to “a serious product quality concern that may have severe consequences”.
The affected batches have been recalled from hospitals, retailers and authorised prescribers, among others.
Sahpra CEO Dr Boitumelo Semete-Makokotlela said: “As a national regulatory authority the recalling of medical products is a crucial measure to address safety concerns or quality issues so we protect the health of the public.”
“Sahpra is recalling these two batches because of reported high levels of diethylene glycol with the potential to cause serious adverse events.”
Diethylene glycol is toxic to humans and can prove lethal, according to Sahpra.
Its effects include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state and acute kidney injury which may lead to death.
TimesLIVE
READ MORE:
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