More African nations recall Johnson & Johnson children’s drug
Drug regulatory authorities in Tanzania, Rwanda and Zimbabwe have issued a recall for a batch of Benylin Pediatric, a children’s cough syrup made by Johnson & Johnson (JNJ), after Nigeria’s food and drug regulator announced elevated levels of toxicity found in tests, Reuters reported on Tuesday.
Three African nations have followed Nigeria, Kenya and South Africa in withdrawing the batch of the cough syrups.
On April 12, the Tanzania Medicines and Medical Devices Authority (TMDA) initiated the recall upon receiving information regarding the Nigerian test findings on the previous day. On the same day, the Rwanda Food and Drugs Authority (FDA) issued “the present recall for precautionary measures.”
The Medicines Control Authority of Zimbabwe (MCAZ) director-general Richard Rukwata stated on Monday that the organization had decided to recall the product.
According to the Nigerian regulator’s report, “laboratory analysis conducted on the product showed that it contains an unacceptable high level of diethylene glycol and was found to cause acute oral toxicity in laboratory animals.”
Diethylene glycol has been reported to cause abdominal pain, an inability to pass urine, and acute kidney injury, which can be fatal.
The batch being recalled was manufactured by JNJ in South Africa in May 2021 and has an expiration date of April 2024, according to the Kenyan Pharmacy and Poisons Board (PPB).
