MHRA response to contaminated paediatric medicines identified in WHO region of Africa

The products referred to in the WHO Medical Product Alert are not authorised for use in the UK and nor are the active ingredients used in any UK authorised products.

If you have acquired any of these cough syrups (Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup) in The Gambia or through informal routes, do not use them. These are substandard products which are unsafe and their use, especially in children, may result in serious injury or death. If you are unsure, please check with your pharmacist.

If you, or someone you know, have used these products, or suffered any side effect after use, you are advised to seek immediate medical attention. We strongly encourage anyone to report any suspected side effects associated with their cough syrup to us via our Yellow Card Scheme website.

Further information

• Laboratory analysis of samples of each of the four products confirm that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.

• Maiden Pharmaceuticals is not named as marketing authorisation holder or manufacturer on any UK licences. Nor it is listed as active substance manufacturer on any licences for other companies. Therefore, no licensed UK medicinal products are likely to be impacted.