Benylin Pediatric Syrup, made by Johnson & Johnson, has been recalled by the National Agency for Food and Drug Administration and Control (NAFDAC).
The product was discovered to contain an unacceptablely high quantity of diethylene glycol and to induce acute oral toxicity in laboratory animals, according to a laboratory investigation done by NAFDAC, which made this announcement on their website yesterday.
When ingested by humans, diethylene glycol is poisonous and can be lethal. Abdominal pain, vomiting, diarrhoea, difficulty urinating, headache, altered mental state, and severe renal impairment that may be fatal are examples of toxic consequences, according to NAFDAC.
Children aged two to twelve years old can benefit from Benylin Paediatric Syrup for the treatment of hay fever and other allergic disorders, as well as for the relief of cough and accompanying congestive symptoms.
Based on the product information, Johnson & Johnson is the manufacturer located in Cape Town, South Africa.
This product, batch number 329304, is set to expire in April 2024 after being created in May 2021.
In order to prevent the importation, distribution, sale, and use of subpar (contaminated) regulated items, NAFDAC has consequently pleaded with importers, distributors, retailers, and consumers to exercise caution and vigilance along the supply chain.
It is mandatory to procure all medical supplies from licensed and recognized vendors. It is important to carefully inspect the products’ physical condition and validity.
It is recommended that anyone in possession of the aforementioned product stop using or selling it right once and turn in any leftover inventory to the closest NAFDAC office. The agency issued a warning: “You are advised to direct such patients for immediate medical attention from a qualified healthcare professional if you witness any adverse reaction or event after the use of this product in any children.”
Healthcare providers and consumers are being advised by NAFDAC to report any suspicions about subpar and counterfeit medications to the NAFDAC office that is closest to them.
Similarly, patients and medical professionals were urged to use the E-reporting platforms on the NAFDAC website or to report any adverse events or side effects connected to the use of the medication to the closest NAFDAC office.
Additionally, the agency instructed Johnson & Johnson Company West Africa, the Marketing Authorization Holder, to start the batch recall. The warning will also be submitted to the WHO Global Surveillance and Monitoring System (GSMS).