The South African Health Products Regulatory Authority (SAHPRA) is recalling a batch of Benylin paediatric syrup as it probes possible high levels of toxic compound, diethylene glycol.
This was after SAHPRA received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding detecting high levels of diethylene glycol in a batch of Benylin paediatric syrup.
SAHPRA RECALLS BENYLIN PAEDIATRIC SYRUP
After being alerted, SAHPRA immediately contacted the South African manufacturer, Kenvue (formerly Johnson and Johnson), for a response.
Following engagements with the manufacturer and in the public’s best interest, it was resolved that affected batches would immediately be recalled while an investigation was ongoing.
SAHPRA, in collaboration with Kenvue, has identified the affected batch numbers as 329304 and 329303. These affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria.
Benylin paediatric presents a clear, bright red syrup with a raspberry odour and taste, packed in amber glass bottles containing 100 ml with a plastic measuring cup.
The syrup treats cough and its congestive symptoms and treating hay fever and other allergic conditions affecting the upper respiratory tract.
The recall is limited to batch numbers 329304 and 329303 of Benylin paediatric syrup.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela has urged the public not to panic as they prioritise the matter.
Semete-Makokotlela said 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.
“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 channel(s) immediately,” Semete-Makokotlela said.
Regarding the classification of recalls, the Benylin paediatric syrup recall is classified as a Class 1 Type A recall, which is associated with a serious product quality concern that may have severe consequences.
The Benylin paediatric syrup product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers, and individual customers or patients.
WHAT IS DIETHYLENE GLYCOL?
Diethylene glycol is a toxic compound associated with the deaths of infants in a number of countries and can be fatal when consumed.
Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury, which may lead to death.
SAHPRA has advised that public members who have consumed these two batches who experience any adverse reaction or witness it in children should consult their healthcare professional and report this using the Med Safety App or email adr@sahpra.org.za.
“As a national regulatory authority, recalling medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public,” Semete-Makokotlela reiterated.
CLICK HERE TO READ MORE ARTICLES BY NOKWANDA NCWANE
