Toxic cough syrup pulled from shelves in South Africa – what you need to know

 ·15 Apr 2024

Johnson & Johnson-made children’s Benylin Paediatric Syrup has been found to contain unsafe levels of a toxic industrial solvent.

The South African Health Products Regulatory Authority (SAHPRA) received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding detecting high levels of diethylene glycol in a cough syrup.

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.

“SAHPRA immediately contacted the South African manufacturer, Kenvue (formerly Johnson and Johnson), for a response.

“Following engagements with the manufacturer and in the public’s best interest, it was resolved that affected batches would immediately be recalled while an investigation was ongoing,” it said.

SAHPRA, in collaboration with Kenvue, have identified the affected batch numbers as:

  • 329304, and
  • 329303.

These affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.

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 Authority noted that Benylin Paediatric is a clear, bright red syrup with a raspberry odour and taste, packed in amber glass bottles containing 100 mL and a plastic measuring cup.

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

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

The manufacturer is a SAHPRA-licenced manufacturer and complies with Good Manufacturing Practices.

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.

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