Kenya has joined several African countries in expressing concerns over Benylin Paediatric, a children’s cough syrup, following recent toxicity findings.
The country along with Tanzania, eSwatini, Rwanda, South Africa, Nigeria and Zimbabwe have all recalled a batch of the pharmaceutical company Johnson and Johnson’s product.
Kenya’s Pharmacy and Poisons Board (PPB) directed pharmaceutical outlets countrywide to stop the distribution of the brand after its Nigerian counterpart recalled the drug over safety issues.
Speaking to the reporters during a briefing, Anthony Toroitich, the Pharmacy Board’s Safety Deputy Director, confirmed that a batch consisting of 11,184 units, which corresponded with its Nigerian counterpart, was potentially toxic.
“In this case of Benylin Paediatric syrup, the Nigerian authority which is called NAFDAC (National Authority for Food and Drug Administration and Control) did a sampling of that medicine in the Nigerian market and they then found that medicine to be of poor quality. The impurity levels of diethylene glycol was higher than expected. So they mandated what we call a ‘recall’ of that product in Nigerian market.”
The recalled batch contained high “impurity levels” of diethylene glycol, according to Toroitich.
Toroitich said that even though the regulatory Board is assessing the other units from three other batches, the ‘Paediatric Benylin’ brand will be under scrutiny.
“We followed it up with the local technical agent in the country who imported those products. We told them to give us the distribution lists and immediately quarantined all Benylin Paediatric-related products’‘.
“In total they were actually about 44,000 (suspected units),” he stated.
The four batches were imported into Kenya in May 2021.
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