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Cough syrup recalled

Publish date: 15 April 2024
Issue Number: 1072
Diary: IBA Legalbrief Africa
Category: Health

Two batches of Benylin cough syrup have been recalled after high levels of diethylene glycol were discovered in the medicine. According to the SA Health Products Regulatory Authority (Sahpra), diethylene glycol is a toxic compound that can be fatal if consumed. News24 reports that Sahpra on Saturday noted that it had received a report from Nigeria's National Agency for Food and Drug Administration and Control about the detection of high levels of the substance. The affected products have the batch numbers 329304 and 329303, and have been distributed to SA, eSwatini, Rwanda, Kenya, Tanzania and Nigeria. CEO Boitumelo Semete-Makokotlela said the regulation body had contacted the medicine's SA manufacturer, Kenvue (formerly Johnson & Johnson), for a response. ‘Following engagements with the manufacturer, and in the best interest of the public, it was resolved that the affected batches would immediately be recalled while an investigation is ongoing,’ Semete-Makokotlela said. He added that recalls are batch-specific and do not necessarily apply to other batches or similar products.

Nigeria and Kenya’s healthcare agencies have also pulled a batch of the syrup off the shelves. IoL reports that the medicine is used to treat cough and congestion symptoms and allergic reactions in children aged two to 12, according to a notice posted on Nigeria’s National Agency for Food and Drug Administration and Control website. ‘Laboratory analysis conducted on the product showed that it contains an unacceptably high level of diethylene glycol and was found to cause acute oral toxicity in laboratory animals,’ the organisation said. This chemical has supposedly been connected to the deaths of scores of children in Cameroon, Gambia and Uzbekistan since 2022, in what is said to be one of the world’s worst epidemics of oral medicine poisoning. Kenvue reportedly said it was conducting its own assessment and testing methodology used.

Full IoL report

Full News24 report

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