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Death of 66 children in Gambi: NAFDAC declares 4 paediatric products unsafe

By Hassan Zaggi

Following the death of 66 children in Gamba after taking substandard products, the National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm over safety of some cough  products.

In a statement by the Management of NAFDAC, the four products include Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

All batches of these products listed above should be considered unsafe.

Laboratory analysis of samples of the four products, according to NAFDAC, confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
in a statement, NAFDAC explained that 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.

“The substandard products in this alert are unsafe and their use, especially in children, may result in serious injury or death.
“The products are not registered by NAFDAC, therefore should not be in circulation.
“To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions,” the statement said.
NAFDAC, therefore, implored importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard cough syrups.

The agency, therefore, advised the general public to always obtained medical products from   authorized/licensed suppliers and that the products’ authenticity and physical condition should be carefully checked.
NAFDAC, therefore, appealed to members of the public in possession of the above listed products to discontinue sale or use and submit stock to the nearest NAFDAC office.
“If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, 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 reaction and substandard and falsified medicines to NAFDAC on 0800-
162-3322 or email: sf.alert@nafdac.gov.ng,” the statement said.

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