Medical Product Alert N°6/2022: Substandard (contaminated) pediatric medicines

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 SyrupMakoff 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 confirms 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.

[1] WHO definitions: https://www.who.int/teams/regulation-prequalification/incidents-and-SF/background/definitions

Medical Product Alert N°6/2022: Substandard (contaminated) pediatric medicines (who. int)

Previous The Official Press Release from the Federal Government of Somalia’s Ministry of Health about the Ebola virus (EVD)

About

©Copyright 2022. FEDERAL MINISTRY OF HEALTH AND HUMAN SERVICES