Johnson & Johnson’s Benylin Paediatrics Syrup has been pulled from shelves by the National Agency for Food and Drugs Administration and Control due to recent laboratory findings indicating toxicity.
NAFDAC revealed that testing revealed dangerously high levels of Diethylene glycol in the syrup, which led to acute oral toxicity in lab animals. The recall was announced by NAFDAC on its official website.
Product recalls, as mentioned by Science Direct, are a vital strategy for managing risks in cases of product safety issues or emergencies. This process involves requesting the return of a specific batch or an entire product line owing to concerns related to safety, design flaws, or labeling inaccuracies.
“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.”
The product’s origin can be traced back to Cape Town, South Africa, where it is manufactured under the brand name of Johnson & Johnson. Identified with batch number 329304, this particular product was produced in May 2021 and is slated to reach its expiration date this April 2024.
In light of these details, NAFDAC has strongly advised all stakeholders involved in the product supply chain—from importers and distributors to retailers and end consumers—to maintain a high level of caution and vigilance. The aim is to prevent the circulation and utilization of any substandard or contaminated regulated products in the market.
NAFDAC underscored the importance of sourcing medical products exclusively from licensed and authorized suppliers. It further stressed the necessity of carefully verifying the authenticity and physical integrity of these products to ensure adherence to quality and safety standards.
“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.
“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: sf.alert@nafdac.gov.ng
- “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 e-mail on pharmacovigilance@nafdac.gov.ng,” he added.
NAFDAC has instructed Johnson and Johnson’s marketing authorization holder in West Africa to begin a recall of the batch.The recall notice will also be posted on the WHO Global Surveillance and Monitoring System.
Wakadaily learnt that, NAFDAC oversees the production, importation, exportation, distribution, advertising, sale, and use of various products including food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents.
