The four pediatric cough syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted healthcare providers and the public of the death of 66 children in Gambia following the use of this four substandard cough syrups, as reported by WHO in September 2022.
Laboratory analysis of samples of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
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 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.
All batches of these products listed above should be considered unsafe. The substandard products in this alert are unsafe and their use, especially in children, may result in severe injury or death.
“If you have these substandard products, please DO NOT use them. Suppose you, or someone you know, have used these products or suffered any adverse reaction/event after use. In that case, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are encouraged to report any suspicion of adverse drug reactions and substandard and falsified medicines to NAFDAC at 0800- 162-3322 or email: firstname.lastname@example.org