NAFDAC Recalls S. African Produced Benylin Cough Syrup, Says It is Toxic

The National Agency for Food and Drugs Administration and Control (NAFDAC) has recalled the Benylin Pediatrics Cough Syrup manufactured by Johnson & Johnson following recent laboratory toxicity findings. The agency announced this on its website on Wednesday.

To recall a product refers to the action taken by NAFDAC to retrieve or withdraw from the market a specific product, in this case, Benylin cough syrup. This action is typically initiated due to safety concerns or regulatory violations associated with the product.

NAFDAC said that Benylin Paediatric syrup is indicated for relieving cough and its congestive symptoms and treating hay fever and other allergic conditions in children aged two to twelve years.

However, laboratory analysis of the product showed that it contained an unacceptably high level of Diethylene glycol and was found to cause acute oral toxicity in laboratory animals, hence the recall.

According to the agency, the Diethylene glycol found in the syrup is toxic to humans when consumed and can prove fatal. It said the poisonous effects of the compound could include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.

The details of the affected product, batch number 329304, manufactured in May 2021 and set to expire in April 2024,  showed that it was produced by Johnson & Johnson in Cape Town, South Africa.

However, NAFDAC has urged importers, distributors, retailers, and consumers to be cautious and vigilant to avoid importing, distributing, selling, and using substandard (contaminated) regulated products.

It said that all medical products must be obtained from authorised/licensed suppliers, and products’ authenticity and physical condition should be carefully checked.

It further stated:

“Anyone in possession of the product mentioned above 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 using this product in children, you are advised to direct such patients to immediate medical attention from a qualified healthcare professional.

“Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: [email protected]

“Similarly, healthcare professionals and patients are also 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 the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via email on [email protected].”

The agency also added that it has directed the marketing authorisation holder (Johnson and Johnson company, West Africa) to initiate the batch recall and that the notice will also be uploaded to the WHO Global Surveillance and Monitoring System.

Read: NAFDAC Bans Sale of Dex Luxury Bar Soap Over Health Concerns

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