The South African Health Products Regulatory Authority (SAHPRA) says no traces of a toxic compound in the Benylin paediatric cough syrup were found.
Also read: Update: SAHPRA recalls two batches of pediatric cough syrup
Two batches of the cough syrup were recalled in April after the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) raised concerns about the product possibly containing high levels of diethylene glycol, which can be toxic to humans when consumed and prove fatal.
Symptoms of consuming diethylene glycol include:
- Abdominal pain,
- Vomiting
- Diarrhoea
- Inability to pass urine
- Headache
- Altered mental state
- Acute kidney injury, which could lead to death
‘The recall was implemented as a precaution to protect lives, while SAHPRA investigated the reported high levels of diethylene glycol,’ SAHPRA said in a statement.
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SAHPRA is authorised to recall health products to address safety concerns and quality issues in the interest of public health, the South African Government News Agency reports.
‘As part of the investigation of the reported high levels of diethylene glycol, SAHPRA tested samples of the two affected batches of Benylin paediatric syrup through an independent laboratory and a method developed by the World Health Organisation for testing products for the presence of diethylene glycol. The tests did not find traces of diethylene glycol in the recalled batches,’ the organisation stated.
‘This indicates that units of batches 329303 and 329304, that were stored at the required temperature, would not contain unacceptable levels of diethylene glycol.’
The watchdog added that there was no record of any adverse drug reactions relating to diethylene glycol for the two recalled batches in South Africa or anywhere else.
‘SAHPRA will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. And we will continue to address safety concerns or quality issues so that the health of the public is protected,’ SAHPRA CEO, Dr Boitumelo Semete-Makokotlela said.
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