COMESA CC issues alert on Contaminated Syrup

The COMESA Competition Commission (“the Commission”) has issued an alert to all its member countries about a substandard/ contaminated syrup that was identified in Cameroon recently.

The CCC in the alert said they had become aware that on 19 July 2023, the World Health Organization (WHO) issued a Medical Product Alert, Medical Product Alert N°5/2023, with regard to a batch of substandard (contaminated) NATURCOLD Syrup identified in Cameroon, and first reported to WHO on 13 March 2023. 

The alert CCC issued, noted that the substandard medicine is marketed by FRAKEN INTERNATIONAL (England). 

"According to WHO, analysis on samples of the NATURCOLD syrup from Cameroon were made available on 27 June 2023 and analysed 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 as much as 28.6%, whereas the acceptable limit for Diethylene Glycol is no more than 0.10%," the CCC wrote in the Alert. 

It said that WHO further warned that Diethylene glycol is toxic to humans when consumed and can prove fatal. 

"NATURCOLD Syrup is therefore 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 affected product has been identified in Cameroon, but it is believed that it may be distributed to other countries or regions through informal markets. 

"The affected product is indicated as below: Product Name Stated Marketer Expiry Dates Batch Number Declared active ingredient NATURCOLD syrup FRAKEN INTERNATIONAL (England) Feb-25 E22053 Paracetamol, phenylephrine hydrochloride, chlorpheniramine maleate.

"The affected product is marketed by FRAKEN INTERNATIONAL (England). The United Kingdom national regulatory authority, the MHRA, has however confirmed that no such manufacturer exists in the UK, and enquires are still underway to determine the origin of the product." 

WHO has appealed to the public not to use the above substandard products, and in cases where the product has been consumed, and one has suffered from adverse reaction, then they are advised to seek immediate medical advice from a qualified healthcare professional.

They should also report any case to their respective National Regulatory Authority or National Pharmacovigilance Centre, or reported to the WHO via rapidalert@who.int. Pursuant to Article 30(1)(b) of the COMESA Competition Regulations.

The Commission also requests any person who establishes that this product is being sold in COMESA, to avoid their purchase or consumption, and to report the matter to the Commission by contacting Mr. Steven Kamukama, Manager Consumer Welfare and Advocacy Division on +265 (0) 1 772466 or by email on: skamukama@comesacompetition.org.