Tanzanian and Rwandan drug regulatory authorities have taken precautionary action by recalling a batch of Johnson & Johnson children’s cough syrup following reports of high toxicity levels from Nigerian laboratory tests.
Joining Nigeria, Kenya, and South Africa in the recall of the affected batch, their decision underscores growing concerns over the safety of the syrup, commonly used to treat coughs, hay fever and other allergic reactions in children. South Africa has gone further by recalling an additional batch of the product.
Tanzanian Medicines and Medical Devices Authority (TMDA) said they began the recall on April 12 after hearing the Nigerian test results.
“This is an exercise that does not involve investigation but monitoring to ensure that those affected drugs are removed from the market,” TMDA spokesperson Gaudensia Simwanza said.
While Rwanda’s Food and Drugs Authority acknowledged no adverse events reported in their safety database, the recall was issued as a precautionary measure in light of the reported high levels of diethylene glycol detected in laboratory tests conducted by Nigeria’s health regulator.
“A review of our safety database doesn’t reveal any adverse events reported,” the Rwanda Food and Drugs Authority said in a statement.
“However, Rwanda FDA issues the present recall for precautionary measures.”
Nigeria’s health regulator detected elevated levels of diethylene glycol in laboratory tests on the syrup. Diethylene glycol has been linked to numerous child deaths in Gambia, Uzbekistan, and Cameroon since 2022, marking one of the deadliest episodes of poisoning from oral medication worldwide.
In response to the growing concerns, Kenvue stated that it is conducting its own assessment of the situation and collaborating with health authorities to determine the appropriate course of action.
Melissa Enoch
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