2023-07-20 09:01:20
Alert Summary
This medical product alert issued by WHO concerns a batch of NATURCOLD syrup of inferior quality (contaminated) identified in Cameroon and notified for the first time to WHO on March 13, 2023. All reasonable precautions have been taken by WHO to verify the information in this alert, which may be updated as new information becomes available.
The declared active ingredients of NATURCOLD syrup are paracetamol, phenylephrine hydrochloride and chlorpheniramine maleate. The combination of these three ingredients works to relieve symptoms associated with colds, flu and allergic rhinitis.
Samples of NATURCOLD syrup from Cameroon were made available to WHO on June 27, 2023 and analyzed in a laboratory under contract and prequalified by WHO. Analysis revealed that the product was contaminated with unacceptable amounts of diethylene glycol. Up to 28.6% diethylene glycol has been detected in NATURCOLD samples. The acceptable limit for diethylene glycol cannot exceed 0.10%.
The declared manufacturer of the affected product is listed on the product packaging as FRAKEN INTERNATIONAL (England). The UK’s national regulatory authority, the MHRA, has confirmed that no company with this designation exists in the UK. Investigations are still ongoing to determine the origin of the product. Accordingly, the mentioned manufacturer has not provided any guarantees to WHO as to the safety and quality of these products.
It is possible that the product mentioned in this alert is subject to marketing authorization in other countries or regions. It may also have been distributed, through informal markets, to other neighboring countries.
Please consult Annex of this alert for complete details on the affected products.
The WHO has already issued four alerts on other contaminated liquid medicines. Please see Medical Product Alert No. 6/2022, Medical Product Alert No. 7/2022, Medical Product Alert No. 1/2023 and Medical Product Alert No. 4/2023.
Risks
Diethylene glycol is toxic to humans when consumed and can be fatal.
The substandard product referenced in this alert is dangerous and its use, especially in children, could result in serious injury or death. Diethylene glycol toxicity is manifested by abdominal pain, vomiting, diarrhea, oliguria or anuria, headache, confusional state and acute kidney injury which may lead to death.
Advice to regulators and the public
If you are in possession of the affected product, WHO recommends that you do not use it. If you (or someone you know) have, or might have, used the product in question, or experienced any adverse reaction or side effects after using it, you should seek medical advice immediately.
WHO recommends increased surveillance and vigilance in supply chains in countries and regions where these products are likely to be found. It is also advisable to strengthen surveillance in informal and unregulated markets. National regulatory authorities or health authorities are requested to notify WHO immediately if such substandard products are discovered in their country.
Manufacturers of liquid drugs, especially syrups containing excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, are encouraged to test for contaminants such as ethylene glycol and diethylene glycol before using them in drug formulation.
Healthcare professionals should report any suspected cases of adverse events related to the use of contaminated medicines to national regulatory authorities or the national pharmacovigilance centre.
If you have any information regarding the manufacture or supply of these products, please contact WHO by email at [email protected].
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