The Medicines Control Authority of Zimbabwe (MCAZ) has advised members of the public against using Benylin Paediatric 100ml Syrup, batch numbers 329303 and 329304 manufactured by Johnson and Johnson, South Africa.
This comes after the National Agency for Food and Drug Administration (NAFDAC) of Nigeria raised alarm over the medicine after laboratory analysis showed that it contains unacceptably high levels of Diethylene glycol, a contaminant which is toxic for humans when consumed.
Sahpra, in collaboration with Kenvue, identified the affected batch numbers as 329304 and 329303, which had been distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
Benylin Paediatric Syrup is used for the relief of coughing and congestive symptoms, as well as for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.
The regulator said the recall was classified as a Class 1, Type A recall, which was associated with a serious product quality concern that may have severe consequences.
The recall was country-wide and the product was being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
Sahpra said diethylene glycol was toxic to humans when consumed and could prove fatal.
It said the toxic effects could include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, an altered mental state and acute kidney injury, which could be fatal.
In South Africa Members of the public who had consumed these two batches and who 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.
