The National Agency for Food and Drug Administration and Control (NAFDAC), has said that it has no record of children dying or falling ill from exposure to a batch of Benylin Paediatric cough syrup manufactured by Johnson & Johnson that was recalled last week, a senior official said on Tuesday.
The agency announced the recall after laboratory tests found an unacceptably high level of diethylene glycol, a potentially toxic substance, prompting regulators in five other African countries to recall the syrup.
The Director of Pharmacovigilance, NAFDAC, Fraden Bitrus, explained that recent child deaths in other African countries linked to contaminated medication prompted increased cough syrup testing and not because of any specific report of harm to children in Nigeria.
“We sampled several products. Some failed and some passed. This particular product had been sampled earlier but we were not thinking of diethylene glycol and because of this, we decided to test the product again”, he said.
Consuming diethylene glycol can result in acute kidney injury. The substance has been linked to the deaths of dozens of children in Gambia, Uzbekistan, and Cameroon since 2022 in one of the world’s worst waves of poisoning from oral medication.
The recalled batch of Benylin Paediatric syrup was made by J&J in South Africa in May 2021, although Kenvue now owns the brand after a spin-off from J&J last year.
Asked whether J&J was working with Kenvue to investigate what had gone wrong, Joe Wolk, chief financial officer of J&J, said: “This is just with Kenvue at this point”.
Kenvue has said it was conducting its assessment and working with health authorities to determine the next steps.
Following Nigeria’s announcement last week, Kenya, South Africa, Tanzania, Rwanda, and Zimbabwe all recalled the same batch of syrup, while South Africa also recalled an additional batch.
