The National Agency for Food and Drugs Administration and Control has recalled Benylin Paediatrics Syrup manufactured by Johnson & Johnson, following recent toxicity findings in the laboratory on the product.
NAFDAC said 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.
The agency disclosed this on its website on Wednesday.
A product recall is an important method of managing risks in response to product safety events and emergencies.
According to an online health portal, Science Direct, a product recall is a request to return to the maker, a batch, or an entire production run of a product, usually over safety concerns, design defects, or labelling errors.
NAFDAC said it had directed the marketing authorisation holder of Benylin Paediatric syrup (Johnson and 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.
“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.