Multiple African countries have issued recall orders for a batch of cough syrup after laboratory tests detected elevated levels of toxicity in the drug.
100 Percent Fed Up named some of the government regulators in Africa that recalled Benylin Pediatric cough syrup:
- Nigeria – National Agency for Food and Drug Administration and Control (NAFDAC)
- Kenya – Pharmacy and Poisons Board (PPB)
- Tanzania – Tanzania Medicines and Medical Devices Authority (TMDA)
- Zimbabwe – Medicines Control Authority of Zimbabwe (MCAZ)
- Rwanda – Rwanda Food and Drugs Authority (RFDA)
- South Africa – South African Health Products Regulatory Authority (SAHPRA)
On April 10, the NAFDAC issued the initial recall order after laboratory tests found an unacceptably high level of diethyline glycol – a chemical toxic to humans – in the cough syrup. The TMDA followed suit on April 12 after receiving information about the Nigerian regulator's lab tests. The RFDA also announced a recall of the cough syrup "for precautionary measures," while MCAZ Director-General Richard Rukwata said his office had also decided to recall the product. (Related: Robitussin cough syrups RECALLED nationwide due to contamination.)
According to the PPB, the batch being recalled was made by Kenvue in South Africa back in May 2021, and has an expiration date of April 2024. Kenvue, originally Johnson & Johnson's consumer healthcare division, was spun off from the parent firm in February 2022. In response to the recalls, the company said in a statement that it was conducting its assessment and working with health authorities to determine a course of action.
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Diethylene glycol responsible for dozens of deaths
According to Russia Today, diethylene glycol "has been reported to cause abdominal pain, an inability to pass urine and acute kidney injury, which can be fatal." The substance 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.
NAFDAC Director of Pharmacovigilance Fraden Bitrus said that his office had been testing cough syrups in response to the 2022 deaths, not because of any specific report of harm to children in Nigeria.
"We sampled a number of products. Some failed and some passed," he said. "This particular product had been sampled earlier, but we were not thinking of diethylene glycol. Because of this, we decided to test the product again."
Many Nigerians rely on imported drugs from large companies such as Kenvue and its predecessor J&J because of a high prevalence of fake and substandard local medications – at almost 17 percent the last time a survey was done in 2005.
According to SAHPRA, there was no record of adverse reactions in South Africa or anywhere in the world linked to the Benylin cough syrup, but added that it will recall a second batch. It added that it was conducting tests and investigations, with the hope that those will be "finalized soon."
The RFDA also found no adverse reactions related to the cough syrup following a review of its safety database, it said in a statement. The Rwandan regulator defended its move to issue a recall, saying it was done so for precautionary measures.
The ZMCA remarked that it did not have a record of the Benylin cough syrup being imported into Zimbabwe. However, it expressed concern about the product entering the local market illegally and promised to step up inspections.
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Watch this clip that discusses Robitussin cough syrup being recalled across the U.S. due to contamination.
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