According to the FDA, Benylin Paediatric (100MLS) Syrup is a cough mixture manufactured by Johnson & Johnson (Ply), South Africa. A statement signed by the Chief Executive Officer (CEO), Dr Delese Mimi Darko, said the action was necessitated by the detection of an 'unacceptable high level' of diethylene glycol (DEG) in the product.

The statement said DEG was a chemical substance poisonous to humans and consuming it could be injurious to human health, causing headache, abdominal pain, vomiting and diarrhoea.

It added that consumption could cause paralysis, convulsion, acute kidney disease and inability to pass urine among others which may lead to death.

Market surveillance

The FDA, in the statement, however, assured the public that the product was not available on the Ghanaian market, having reviewed all the data on the importation of the product to the country from 2021 to date.

“Ongoing market surveillance efforts across the country so far confirm the absence of the lot in Ghana.  The authority has heightened its surveillance activities at the ports to prevent the entry of LOT No. 329304 onto the Ghanaian market,” the statement gave assurance.

It further said since 2022, all syrup formulations imported into the country were sampled at the port of entry and where necessary, tested for the presence of both DEG and ethylene glycol.

The FDA indicated that it had screened samples of other lots of Benylin Paediatric 100ml syrup available on the Ghanaian market for the presence of DEG, however, the results turned out to be negative.

“The public is hereby cautioned to look out for the affected lot of the Benylin Paediatric Syrup and report to any of our offices across the country,” it stated.