HQ Team
July 20, 2023: The WHO has sounded a global alert on a batch of substandard cough syrup found in Cameroon, which has high levels of a toxic ingredient, diethylene glycol.
The incident involving Naturcold syrup was first reported on March 13, 2023. The stated manufacturer of the affected product is listed on the product packaging as Fraken International, England.
“The United Kingdom national regulatory authority, the MHRA, has confirmed that no such company exists in the UK,” and inquiries were still underway to determine the origin of the product, according to a statement from the WHO.
The active ingredients of Naturcold were stated as paracetamol, phenylephrine hydrochloride & and chlorpheniramine maleate.
Rhinitis
The combination of these three ingredients is used to relieve symptoms associated with the common cold, flu, and allergic rhinitis or inflammation of the inside of the nose.
Samples of the Naturcold syrup from Cameroon were made available to WHO on June 27, 2023, and analyzed in a WHO-contracted and prequalified laboratory.
The analysis found that the product contained unacceptable amounts of diethylene glycol as contaminants.
Diethylene glycol was detected in samples of Naturcold was about 28.6%, while the acceptable limit was no more than 0.10%.
Manufacturer unknown
Since the stated manufacturer is unknown, the guarantees to WHO were not provided on the safety and quality of these products.
The product may have marketing authorizations in other countries or regions. It may also have been distributed through informal markets to neighboring countries, according to the WHO’s alert.
Naturcold is unsafe and its use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
The WHO called for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market was also advised.
Gambia, Indonesia, Uzbekistan
National regulatory authorities/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.
Last October about 300 children were killed after they consumed similar products made by other manufacturers. The deaths occurred in three countries — Gambia, Indonesia, and Uzbekistan.
The deaths in Gambia were traced to an Indian company, Maiden Pharmaceuticals.
This WHO Medical Product Alert in October last year was issued on four substandard products. The four products were Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough Syrup, and Magrip N Cold Syrup.
“The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.”
