The SA Health Products Regulatory Authority (Sahpra) together with the South African manufacturer of Benylin Paediatric Syrup – Kenvue (formerly Johnson & Johnson) – have recalled two batches of the cough medication, sold in six African countries, after laboratory findings in Nigeria showed potentially deadly levels of toxicity.
In a statement released on Saturday night, Sahpra CEO Boitumelo Semete-Makokotlela said the recall of medical products was a crucial measure taken by the national regulatory authority to address safety concerns or quality issues in order to protect public health.
“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,” she said.
Sahpra said it received a report from Nigeria’s National Agency for Food and Drug Administration and Control (Nafdac) on April 10 regarding the detection of high levels of diethylene glycol in a batch of Benylin Paediatric Syrup.
As a result, Sahpra immediately contacted the South African manufacturer Kenvue for a response, and it was then resolved that affected batches would immediately be recalled in the best interest of the public while an investigation is ongoing.
Sahpra, in collaboration with Kenvue, identified the affected batch numbers as 329304 and 329303, which had been distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
Benylin Paediatric Syrup is used for the relief of coughing and congestive symptoms, as well as for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.
The regulator said the recall was classified as a Class 1, Type A recall, which was associated with a serious product quality concern that may have severe consequences.
The recall was country-wide and the product was being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
Sahpra said diethylene glycol was toxic to humans when consumed and could prove fatal.
It said the toxic effects could include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, an altered mental state and acute kidney injury, which could be fatal.
Members of the public who had consumed these two batches and who experienced any adverse reaction, or witnessed it in children, should consult their healthcare professional and report this using the Med Safety App, or send an email to: [email protected].
Sahpra said it had alerted healthcare professionals and the public to discontinue the use of the two batches mentioned, remove them from their inventory and return them to their normal distribution channel(s) with immediate effect.
In December last year, the government agency recalled the Lubri-A Sterile Lubricating Sachets (Glycerine (B.P. Or U.S.P) 9.9% M/M manufactured by Electro Spyres Healthcare, following a countrywide outbreak among patients who developed a rare fungal pathogen, Wickerhamomyces anomalus (previously Candida pelliculosa), following the use of Lubri-A.
Following a collaborative investigation, the source was found to have been contaminated batches of the product, Lubri-A-Sterile Lubricating 2.5 g Jelly sachets.
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