The Pharmacy and Poisons Board (PPB) of Kenya issued a public alert on April 11, 2024, calling for the immediate recall of Benylin pediatric 100mls cough syrup Batch No 329304, manufactured by Johnson & Johnson in South Africa.
This is after the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria detected high levels of diethylene glycol in the product, which is toxic to humans and can be fatal.
Diethylene glycol is a toxin that can cause abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.
“This cough syrup manufactured by Johnson & Johnson (Pty), South Africa, is being recalled due to quality concerns arising from an unacceptable high level of diethylene glycol detected through laboratory analysis conducted by NAFDAC.” noted the PPB in the statement.
The product in question was manufactured in May 2021 and has an expiry date of April 2024.
Likewise, the Board noted that it had launched an investigation into the supply chain of the affected medicine batch and has taken the necessary steps of sampling other batches of the same product for further analysis.
“The PPB also initiated rapid response, which includes sampling of batches of Benylin pediatric 100mls syrup that are within shelf life for the purpose of screening of the levels of Ethylene glycol and diethylene glycol,” noted the board.
“Subsequent implementation of regulatory actions will be based on the laboratory findings.”
Also Read: President Ruto: Africa Must Manufacture its Own Medicines
Details of the Medicine
Benylin syrup is a medication used to treat coughs in children and is specially formulated to provide relief for dry and tickly coughs in children aged 1 year and over.
The syrup contains ingredients like glycerol and sugar that help soothe inflamed areas of the throat, providing comfort for children experiencing cough symptoms.
The syrup is non-drowsy and has a blackcurrant flavor, making it more palatable for children.
PPB Warns Against Circulation of the Medicine
PPB has advised all pharmaceutical outlets, healthcare facilities, healthcare workers, and members of the public to immediately quarantine the product and stop its distribution, sale, issuing, or use.
Furthermore, the public is advised to return the product to the nearest healthcare facility, while healthcare facilities on the other hand are advised to return the products to their respective suppliers.
However, the board notes that the alert affects only the specified batch number 329304 of the product “Benylin pediatric 100mls syrup.”
The Pharmacy’s board assured the public that it has established mechanisms to ensure that medicines supplied to the Kenyan market meet the required quality, safety, and efficacy standards.
Additionally, patients who experience reactions following the use of the product are advised to seek immediate medical attention from qualified healthcare professionals.
“The public or patients who experience adverse reaction/events following the use of this product in children, are advised to direct such patients for immediate medical attention from a qualified healthcare professional,” said the board.
Also Read: 129 Arrested in Crackdown on Illegal Pharmaceuticals
PPB’s Call to Action
The public has been urged to maintain vigilance and report any suspected poor-quality medicines or adverse drug reactions to the nearest healthcare facility and the Pharmacy and Poisons Board via various channels, including the PPB mobile application, USSD code, email, and the PPB website.
The Pharmacy and Poisons Board is the national regulatory authority responsible for ensuring the quality, safety, and efficacy of medical products, including medicines, medical devices, and other health technologies, in Kenya.
Also, the boards is responsible for protecting the public from the risks associated with the use of poor-quality medicines and medical devices.
