Health

Gov’t halts sale of Benylin cough syrup, warns public against purchase

Benylin Paediatric cough syrup.

By John Mbati | Thursday, April 11, 2024

Patients who had consumed the product, were advised to immediately seek medical attention from a qualified healthcare professional.

The Pharmacy and Poisons Board (PPB) has ordered pharmacies to immediately stop selling a cough syrup that has been perceived to be deadly until investigations into its production and safety are concluded.

In a statement dated Thursday, April 11, 2024, PPB chief executive officer Fred Siyoi recalled the Benylin Paediatric 100-ml cough syrup Batch No. 329304 from the market with immediate effect.

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Siyoi stated that the decision was arrived at after Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) recalled the drug from the market.

“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.

“Diethylene glycol is a contaminant which 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,” Siyoi warned.

He emphasised that the batch under investigation was manufactured in May 2021, with an expiration date set as April 2024.

PPB takes action

PPB immediately commenced investigations, including initiating a rapid response, which entails sampling batches of Benylin Paediatric 100ml syrup that are within shelf life for screening of the levels of ethylene glycol and diethylene glycol.

Before taking regulatory actions, which will be based on the laboratory findings, PPB directed all pharmaceutical outlets, healthcare facilities, healthcare workers, and the public to immediately halt the distribution, sale, issuance, or use of the product.

“Furthermore, the public is advised to return the product to the nearest healthcare facility, while healthcare facilities are advised to return the products to the respective suppliers,” PPB directed, stating that the order affects only the batch number announced.

Patients, including children who had consumed the product, were advised to immediately seek medical attention from a qualified healthcare professional.

“PPB would like to assure the public that we have established mechanisms to ensure that medicines supplied to the Kenyan market meet the required Quality, Safety and Efficacy standards. We encourage the public to be vigilant at all times and report any suspected poor-quality medicines or adverse drug reactions to the nearest healthcare facility and the Pharmacy and Poisons Board,” Siyoi added.