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Rwanda, Tanzania and Zimbabwe Recall Johnson & Johnson Children’s Cough Syrup


FILE image of cough syrup being poured into a spoon
FILE image of cough syrup being poured into a spoon

KIGALI, RWANDA — Drug regulators in Tanzania, Rwanda and Zimbabwe have recalled a batch of Johnson & Johnson children's cough syrup as a precautionary measure after their Nigerian counterpart said laboratory tests found high levels of toxicity.

The three nations join Nigeria, Kenya and South Africa in recalling the same batch of the syrup, which is used to treat coughs, hay fever and other allergic reactions in children. South Africa has also recalled an additional batch.

Laboratory tests on the syrup by Nigeria's health regulator showed a high level of diethylene glycol, which 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.

Diethylene glycol is toxic to humans when consumed and can result in acute kidney failure.

The batch of Benylin Paediatric syrup recalled was made by J&J in South Africa in May 2021, although Kenvue now owns the brand after a spin-off from the multinational pharmaceutical company last year.

Tanzania Medicines and Medical Devices Authority, TMDA said it had begun the recall on April 12 after hearing about the Nigerian test results.

"This is an exercise that does not involve investigation but rather monitoring to ensure that those affected drugs are removed from the market," TMDA spokesperson Gaudensia Simwanza said on Monday.

A spokesperson for Kenya's drug regulator said its test results on the syrup would likely be ready on Wednesday.

"A review of our safety database doesn't reveal any adverse events reported," the Rwanda Food and Drugs Authority said in a statement dated April 12.

"However, Rwanda FDA issues the present recall for precautionary measures," the statement added.

Zimbabwe's Medicines Control Agency said that it did have a record of the product's importation into the southern African nation, but that it was concerned the syrup could enter the local market illegally.

Zimbabwean authorities say the nation will step up inspections as a precautionary measure.

Kenvue said in a statement that it was conducting its own assessment and working with health authorities to determine a course of action.

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