SAHPRA recalls two batches of Benylin Paediatric Syrup
High levels of a toxic substance were detected in the medicines.
Picture: Pexels
Lester Kiewit speaks to Deon Poovan, SAHPRA Senior Manager: Inspectorate and Regulatory Compliance.
The South African Health Products Regulatory Authority (SAHPRA) is investigating reports of a dangerous solvent allegedly found in two batches of Benylin Paediatric Syrup - the syrup is made by Kenvue and manufactured in South Africa.
This comes after the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) shared a report on the detection of high levels of diethylene glycol in the medications.
The affected batches, 329303 and 329304, contain diethylene glycol, which is toxic to humans and can be fatal if consumed in high doses.
SAHPRA reported that these batches would immediately be recalled.
It said affected countries included South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria.
Poovan says the toxic ingredients might have been added or received in error during manufacturing.
"It might have been added in error or received in error from a contact supplier."
Deon Poovan, SAHPRA Senior Manager
Symptoms of ingesting this toxic chemical could be abdominal pain, vomiting, diarrhoea, the inability to pass urine, headaches, an altered mental state, acute kidney injury and in some cases, death.
The authority said it had also started alerting healthcare providers, and called on consumers of the products showing adverse side effects to visit a doctor.
Poovan says there's "no need for public panic as the toxic ingredient has only been limited to these batches".
If you have a bottle in a box or bottle with lot number at the bottom with batch numbers: 329303 and 329304, discard it.
"At this stage, it does not affect any of the other Benylin products manufactured by Kenvue. There have been no reports of adverse events."
Deon Poovan, SAHPRA Senior Manager
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