Medical Product Alert N°6/2022
Substandard (contaminated) paediatric medicines identified in WHO region of Africa
Alert Summary
This WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that fail to meet either their quality standards or specifications and are therefore "out of specification"1.
The four products are 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.
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.
