CONTAMINATED BENYLIN PAEDIATRIC SYRUP (100MLS), LOT NO. 329304

The Food and Drugs Authority (FDA) wishes to inform the public of the recall of Benylin Paediatric (100mls) Syrup, LOT No 329304 by the Nigeria National Agency for Food and Drugs Administration (NAFDAC) from the Nigerian market. Benylin Paediatric Syrup is a cough mixture manufactured by Johnson & Johnson (Pty), South Africa. The recall was necessitated by the detection of an "unacceptable high level" of diethylene glycol (DEG) in the product.

DEG is a chemical substance poisonous to humans and consuming it could be injurious to health, causing headache, abdominal pain, vomiting, diarrhoea, paralysis, convulsion, acute kidney disease and inability to pass urine among others, which may lead to death.

The FDA hereby assures the public that LOT No. 329304 is not available on our market, having reviewed all the data on the importation of the product to Ghana from 2021. Ongoing market surveillance efforts across the country so far confirm the absence of the lot in Ghana. The Authority has also heightened its surveillance activities at the ports with the view to prevent the entry of LOT No. 329304 onto the Ghanaian market.

Additionally, as a precaution, since 2022, all syrup formulations imported into the country are sampled at the port of entry and where necessary, tested for the presence of both DEG and ethylene glycol. Finally, the FDA has screened samples of other lots of Benylin Paediatric 100mls syrup available on the Ghanaian market for the presence of DEG and 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.

For further information, please contact the FDA.