The National Agency for Food and Drug Administration and Control (NAFDAC) has recalled Benylin Paediatric Syrup, manufactured by Johnson & Johnson, after determining it contains toxic levels of Diethylene glycol.
In a statement on its website, NAFDAC revealed that laboratory tests on the syrup found it to have high levels of Diethylene glycol, which is known to be toxic and potentially fatal to humans. The agency stated that consuming the contaminated syrup can lead to symptoms such as abdominal pain, vomiting, diarrhea, difficulty urinating, headache, altered mental state, and acute kidney injury, which could be fatal.
Benylin Paediatric Syrup is designed to relieve cough and its congestive symptoms, as well as treat hay fever and other allergic conditions in children aged two to 12 years. The product, manufactured in Cape Town, South Africa, has a batch number of 329304 and was produced in May 2021. It is set to expire this month, April 2024.
NAFDAC advised importers, distributors, retailers, and consumers to exercise caution and avoid the importation, distribution, sale, and use of the contaminated product. It also urged those in possession of the syrup to discontinue use and submit stock to the nearest NAFDAC office.
Healthcare professionals and patients were encouraged to report any adverse events or side effects from the use of the syrup to the nearest NAFDAC office or use the agency’s E-reporting platforms available on its website.
Additionally, NAFDAC instructed Johnson & Johnson Company West Africa to initiate the recall of the batch, and the recall notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
