Nairobi (Agencies): Kenya’s pharmaceutical regulatory body, the Pharmacy and Poisons Board (PPB), has announced the recall of a batch of Johnson & Johnson’s children’s cough syrup, Benylin Pediatric. The recall was triggered by concerns over the presence of a potentially lethal toxic substance in the product.
The PPB’s decision was influenced by a similar recall initiated by the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria. The syrup, which is also used to alleviate hay fever and other allergies in children aged between two and twelve, is now under scrutiny.
The batch in question was produced by Johnson & Johnson in South Africa in May 2021 and is set to expire in April 2024. The PPB has expressed concerns that the batch may contain dangerously high levels of the contaminant diethylene glycol.
The PPB has advised all healthcare facilities, pharmaceutical outlets, healthcare workers, and the public to immediately isolate the product and cease its distribution, sale, and use. This directive was issued by the poisons board of the East African nation.
NAFDAC, Nigeria’s drug regulatory authority, had previously announced the recall of a batch of the same medication due to findings of laboratory toxicity. According to a public notice published on NAFDAC’s website, laboratory tests on the product revealed an unacceptably high level of diethylene glycol, which was found to cause acute oral toxicity in laboratory animals.
Diethylene glycol has been associated with symptoms such as abdominal pain, urinary retention, and acute kidney injury, which can be fatal. It has been implicated in the deaths of several children in Gambia, Uzbekistan, and Cameroon since 2022, who consumed cough syrups manufactured in India.