It’s that time of the year.
There are sniffles, coughs and sneezes all around as temperatures drop and people are getting sick.
The South African Health Products Regulatory Authority (SAHPRA) has recalled two batches of Benylin paediatric syrup because of high levels of diethylene glycol were detected.
Diethylene glycol is toxic to humans when consumed and can be fatal. 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.
Benylin Paediatric presents as a clear, bright red syrup having a raspberry odour and taste, packed in amber glass bottles containing 100 mL with a plastic measuring cup. It is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela say as part of their core function, this is an important issue to address.
“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events,”
SAHPRA had initially received a report from Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), and SAHPRA contacted the South African manufacturer, Kenvue (formerly Johnson and Johnson) for a response.
The regulatory body engaged Kenvue, and in the best interest of the public, it was resolved that affected batches would immediately be recalled while an investigation is ongoing.
SAHPRA, in collaboration with Kenvue, have 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.
The recall is classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a country-wide recall. The product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
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) with immediate effect.
