The SA Health Products Regulatory Authority (SAHPRA) has recalled two Benylin cough syrup batches which it says contains toxic, fatal compound. This is after the authority received a report from the Nigerian National Agency for Food and Drug Administration and Control regarding the detection of high levels of diethylene glycol in a batch of Benylin Paediatric Syrup.
According to SAHPRA, diethylene glycol is toxic to humans when consumed and can prove fatal and toxic. In a statement yesterday, SAHPRA said the affected products come from batches numbers 329304 and 329303, and have been distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria. The authority’s chief executive Dr Boitumelo Semete-Makokotlela said they immediately contacted the SA, Kenvue , formerly Johnson and Johnson for a response and that after an engagement with the manufacturer, they resolved to recalling the batches with immediate effect while an investigation is being conducted. “As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events,” Semete-Makokotlela said.
SAHPRA has also pleaded with the public to not panic as the matter is being handled with priority. “Recalls are batch-specific and do not necessarily apply to other batches or similar products. The public is reminded that the recall is limited to two batches and should not panic regarding the range of products bearing the same name,” the statement said. The authority also pleaded with healthcare professionals and the public to discontinue the use of the two batches mentioned and return them to their normal distribution channels with immediate effect. “The recall is classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a country-wide recall,” the authority said.
DR Semete-Makokotlela advised those who have consumed syrup from the bad batches and are experiencing any adverse reaction or witness it in children should consult their healthcare professional. According to SAHPRA, toxic effects of diethylene glycolcan include abdominal pain, vomiting, diarrhea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to d3@th.
Source Zimoja
