National Agency for Food and Drugs Administration and Control (NAFDAC) has recalled Benylin Paediatric Syrup, manufactured by Johnson & Johnson.
NAFDAC, which disclosed this on its website yesterday, explained that the laboratory analysis conducted on the product showed that it contained an unacceptably high level of Diethylene glycol and was found to cause acute oral toxicity in laboratory animals.
“Diethylene glycol is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death”, NAFDAC said.
Benylin Paediatric Syrup is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions in children aged two to 12 years.
The details of the product showed that it was manufactured by Johnson & Johnson in Cape Town, South Africa.
With batch number 329304, the product was manufactured in May 2021, and it is to expire this month, April 2024.
NAFDAC has therefore implored importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard (contaminated) regulated products.
“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
“Anyone in possession of the above-mentioned product is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office. If you witness any adverse reaction/event after the use of this product in any children, you are advised to direct such patients for immediate medical attention from a qualified healthcare professional”, the agency cautioned.
Meanwhile, NAFDAC has urged healthcare professionals and consumers to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office.
Similarly, healthcare professionals and patients were encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on its website.
Also, the agency directed the Marketing Authorisation Holder (Johnson & Johnson Company West Africa) to initiate the recall of the batch and the notice will also be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
