SAHPRA recalled two batches of Benylin paediatric cough syrup on Monday, April 15. The medication is said to have high levels of diethylene glycol which is toxic to humans and could prove fatal.
The South African Health Products Regulatory Authority (SAHPRA) has recalled two batches of Benylin paediatric cough syrup. It was found that the cough syrup has high levels of diethylene glycol detected in it. SAHPRA said this was toxic to humans when consumed and could prove fatal.
On April 10, the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) reported to the concerned party that a batch of Benylin paediatric cough syrup had high levels of diethylene glycol detected in it.
Toxic effects of the compound can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury that may lead to death.
“SAHPRA immediately contacted the South African manufacturer, Kenvue, formerly Johnson and Johnson, for a response. 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 said in a statement.
The affected batch numbers are 329304 and 329303.
SAHPRA, in collaboration with Kenvue, has identified the affected batch numbers as 329304 and 329303. These affected batches have been distributed to several countries including South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
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 that they protect the health of the public.
“SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse effects,” said Dr Semete-Makokotlela.
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.
“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 or similar products. The manufacturer is a SAHPRA-licenced manufacturer and complies with Good Manufacturing Practices (GMP),” said Dr Semete-Makokotlela.
“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.”
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.
According to SAHPRA, this is a countrywide recall and it 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
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