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: BenylinDiethylene 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
Comments