11.01.2024 19:27
Health authorities order therapeutic goods manufacturer to recall finished products manufactured using contaminated solvent.
Pakistani health authorities on Thursday said they seized contaminated propylene glycol solvent used in cough syrup which could lead to serious health risks.
The Drug Regulatory Authority of Pakistan (DRAP) said its field force has identified a batch of propylene glycol (PG) that was used as a solvent in the manufacturing of oral liquid preparations.
"The batch was labeled as manufactured by Dow Chemical, Thailand. However, on analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of ethylene glycol was found," said DRAP in its rapid alert.
The authority further said that ethylene glycol (EG) contaminated propylene glycol (PG), when used in oral liquid preparations, can lead to serious health risks due to EG's toxicity.
It added that when ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
DRAP also directed the therapeutic goods manufacturer to recall any finished products that were manufactured using the same lot of propylene glycol.
"The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market," it said.
Last year in January, the World Health Organization reported more than 300 deaths of children in three countries – Indonesia, Gambia, and Uzbekistan – because of confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol in cough syrups. -