WHO’s substandard medicines not registered in Ghana – FDA
The medicines are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The FDA in a statement issued in Accra on Thursday following the WHO’s alert, said the products according to Who, were substandard because laboratory analysis of samples of each of the four products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
It said the manufacturer of the products, Maiden Pharmaceuticals Limited (Haryana, India), had also not provided guarantees to WHO on the safety and quality of the products as of 5th October 2022.
The statement said Diethylene glycol and ethylene glycol were toxic to humans when consumed and could prove fatal.
Toxic effects of the identified substance include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.
“These products have not been registered by the FDA and are not expected on the Ghanaian market, however, they may have been distributed illegally,” the FDA said.
The FDA advised all healthcare professionals to report suspected falsified medicinal products by completing the Adverse React Form online using the link http://adr.fdaghana.gov.gh or call Mobile no: 024431 0297 or send an email to email@example.com.
The statement said the FDA had strengthened its post market surveillance activities at the borders and across the country with the view to identify and withdraw any unregistered product on the Ghanaian Market.