By Lucy Adautin
Drug regulatory authorities in East African countries – Tanzania and Rwanda have initiated a recall of a specific batch of Johnson & Johnson children’s cough syrup as a precautionary step.
This action follows the announcement by their Nigerian counterpart, which reported elevated levels of toxicity in laboratory tests.
The two countries join Nigeria, Kenya, and South Africa in recalling the same batch of the syrup, commonly used to address coughs, hay fever, and other allergic reactions in children. Additionally, South Africa has recalled an extra batch.
Tests conducted on the syrup by Nigeria’s health regulator revealed elevated levels of diethylene glycol, a substance associated with the deaths of numerous children in The Gambia, Uzbekistan, and Cameroon since 2022. This incident marks one of the world’s most severe instances of poisoning from oral medication.
The batch recalled was made by J&J in South Africa in May 2021, although Kenvue now owns the Benylin Paediatric syrup brand after a spin-off from J&J last year.
The Tanzania Medicines and Medical Devices Authority (TMDA) said they 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 told Reuters 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, the Rwanda FDA issues the present recall for precautionary measures.”
Kenvue stated in a release that it is conducting its own evaluation and collaborating with health authorities to decide on the appropriate course of action.
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