SAHPRA recalls two batches of Benylin cough syrup

BATCH:  The regulatory body says it received a report from the Nigerian authorities that the flu remedy contains a toxic and fatal compound…

By Lehlohonolo Lehana

SA Health Products Regulatory Authority (SAHPRA) says it has recalled two batches of Benylin cough syrup after high levels of diethylene glycol were discovered in the medicine.

The affected batch numbers are 329304 and 329303. SAHPRA said it received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) on April 10, regarding the detection of high levels of diethylene glycol in these batches of Benylin Paediatric Syrup.

Following engagements with the South African manufacturer, Kenvue (formerly Johnson and Johnson), it was resolved that affected batches would immediately be recalled while an investigation is ongoing.

“The affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria,” said SAHPRA CEO Dr Boitumelo Semete-Makokotlela.

Benylin Paediatric presents as a clear, bright red syrup having a raspberry odour and taste, packed in amber glass bottles containing 100 ml with a plastic measuring cup.

It is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.

 “SAHPRA wishes to inform the public not to panic as the matter is being handled with priority. Batch recalls are batch-specific and do not necessarily apply to other batches/similar products,” said Semete-Makokotlela.

“The manufacturer is a SAHPRA-licenced manufacturer and complies with good manufacturing practices.” 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, according to Semete-Makokotlela.

SAHPRA is alerting 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.

Classification of the recalls

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 product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.

What the public should know

Diethylene glycol is toxic to humans when consumed and can prove fatal.

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death.

Members of the public who have consumed these two batches who experience any adverse reaction or witness it in children should consult their healthcare professional and report this using the Med Safety App or send an email to: adr@sahpra.org.za. – www.fullview