Two batches of Benylin Paediatric syrup recalled by SAHPRA

Two batches of Benylin Paediatric syrup have been recalled after high levels of diethylene glycol were detected.

COURTESY: Benylin

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.

The South African Health Products Regulatory Authority (SAHPRA) said it received a report from the Nigerian Agency for Food and Drug Administration and Control last week Wednesday regarding the detection of diethylene glycol in the medicine.

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 immediately contacted the South African manufacturer, Kenvue (formerly Johnson and Johnson) for a response. Following engagements with the manufacturer and in the best interest of the public, it was resolved that affected batches would immediately be recalled while an investigation is ongoing,’’ said Dr Boitumelo Semete-Makokotlela, SAHPRA CEO.

SAHPRA said the affected products only includes batch numbers 329304 and 329303. It said these affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.

‘’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. 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,’’ said Dr Boitumelo Semete-Makokotlela, SAHPRA CEO.

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

‘’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.’’

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.

“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,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

 

Done By: Mitchum George