NAFDAC recalls J&J Benylin children cough syrup over ‘toxicity findings’
The National Agency for Food and Drug Administration and Control has recalled Benylin, a children’s cough syrup manufactured by Johnson & Johnson from the market “following recent toxicity findings.”
The NAFDAC, in a statement on Wednesday said the recall became imperative after laboratory analysis showed that the current batch of Benylin, due to expire in April 2024, contained “an unacceptable high level of diethylene glycol.”
Cough syrups containing high quantities of diethylene have been connected to a large number of children deaths in Cameroon and The Gambia in 2022 and 2023
At least 66 children lost their lives in The Gambia, triggering the World Health Organisation, to issue an alert to citizens warning them of diethylene glycol, known to be deadly in high levels.
The WHO noted that consequences include acute kidney injury, diarrhoea, altered mental state, inability to pass urine, headache and vomiting.
NAFDAC said that the ingredient in Benylin “was found to cause acute oral toxicity in laboratory animals” despite the cough syrup’s marketing claims to treat cough, congestive symptoms, hay fever and allergic conditions in children between two and 12 years old.
The Johnson & Johnson batch in question, with the number 329304, was produced in Cape Town, South Africa in May 2021 and scheduled to expire this month.
It’s unclear how many bottles of Benylin must have been sold within its three years of circulation and how many children were affected since NAFDAC recently detected the toxic substance.
NAFDAC advised Nigerians to shun the syrup and asked pharmacies to discontinue its sale.
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