NAFDAC recalls cough syrup Bennylin over toxicity concerns
The National Agency for Food and Drug Administration and Control has recalled Johnson & Johnson’s Benylin Paediatrics Syrup due to recent test adverse results.
According to NAFDAC, the product’s laboratory investigation found an unacceptably high quantity of diethylene glycol, resulting in acute oral toxicity in test animals.
The agency announced this on its website on Wednesday.
A product recall is an important risk-management tool for responding to product safety incidents and crises.
According to Science Direct, a product recall is a request to return a batch or an entire production run of a product to the manufacturer due to safety concerns, design flaws, or labelling problems.
“Benylin paediatric syrup is used to treat coughs and congestive symptoms, as well as hay fever and other allergic diseases in children aged two to twelve years old.”Diethylene glycol is harmful to humans and can be lethal.” Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may result in death,” it stated.
According to the product information, Johnson & Johnson manufactured it in Cape Town, South Africa.
The product, batch number 329304, was made in May 2021 and is set to expire this month, April 2024.
However, NAFDAC urged importers, distributors, retailers, and consumers to exercise caution and monitoring throughout the supply chain to avoid importing, distributing, selling, or using inferior (contaminated) regulated items.
It stated that all medical supplies must be bought from approved or licensed vendors. A thorough examination of the product’s legitimacy and physical quality is necessary.
“We recommend that anyone in possession of the aforementioned product immediately halt sales or usage and return stock to the nearest NAFDAC office.
” If you notice any adverse reactions or events in children after using this medication, please contact a certified healthcare practitioner immediately.
Healthcare professionals and consumers should report any suspicions of substandard or falsified medications to the nearest NAFDAC office.
The statement also encourages healthcare professionals and patients 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 e-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, via the Med-Safety application available for download on Android and iOS stores, or via e-mail at pharmacovigilance@nafdac.gov.ng.
Meanwhile, the agency stated that it has instructed the marketing authorization holder (Johnson & Johnson Company, West Africa) to commence the recall of the batch and that the alert would be posted to the WHO Global Surveillance and Monitoring System.
NAFDAC is responsible for the production, importation, exportation, distribution, advertising, sale, and usage of food, medicines, cosmetics, medical equipment, packaged water, chemicals, and detergents.
By Nnaemeka Odenigbo
