The public has been advised not to panic in regards to the variety of items branded under the Benylin name.
This came about as a result of the product’s two batches being cancelled due to the discovery of diethylene glycol, a poisonous substance that can be lethal to people.
The South African Health Products Regulatory Authority (SAHPRA) recalled both batches over the weekend.
Acute renal injury
According to Dr Boitumelo Semete-Makokotlela, the CEO of SAHPRA, diarrhoea, vomiting, abdominal pain, headaches, a changed mental state, and acute renal injury, which can be fatal, are among the harmful effects of diethylene glycol.
“SAHPRA wishes to inform the public not to panic as the matter is being handled with priority,” said Semete-Makokotlela.
“Members of the public who have consumed these two batches who experience any adverse reaction or witness it in children should consult their healthcare professional.”
In addition to treating hay fever and other upper respiratory tract allergy disorders, Benylin is frequently used to alleviate coughing.
Benylin Paediatric Syrup
Semete-Makokotlela said the Nigerian National Agency for Food and Drug Administration and Control found high levels of diethylene glycol in a batch of Benylin Paediatric Syrup, which prompted the regulatory body to flag the products.
SAHPRA sought a response right away from the manufacturer, Kenvue (previously Johnson and Johnson), in South Africa.
“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,” she added.
The impacted batch numbers are 329304 and 329303, according to SAHPRA and Kenvue’s report.
Nigeria, Kenya, Tanzania, Rwanda, South Africa, and Eswatini are the nations that received the impacted batches.
High levels of diethylene glycol
As a national regulatory body, Semete-Makokotlela stated that recalling medical products is an essential step in addressing safety.
“SAHPRA recalled these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events,” she indicated.
“This is a countrywide recall. The product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers, and individual customers or patients.”
Additionally, SAHPRA issued a warning to the public and medical professionals to stop using the two batches immediately, remove them from inventory, and return them through their regular distribution channel(s).
