The World Health Organisation (WHO) on Monday flagged a batch of ‘contaminated’ common cold syrup in Iraq manufactured by an Indian pharmaceutical company, Fourrts (India) Laboratories
WHO referred to one batch of substandard or contaminated syrup – Cold Out (Paracetamol and Chlorpheniramine Maleate) – in Iraq which was reported to the WHO on July 10.
“The stated manufacturer of the affected batch of the product is FOURRTS (INDIA) LABORATORIES PVT. LTD and the product is stated to be manufactured for DABILIFE PHARMA PVT. LTD. – INDIA,” WHO said.
Paracetamol and chlorpheniramine combination syrups are used to treat and relieve symptoms of the common cold and allergy.
The WHO said the batch of the syrup had a higher than acceptable limit of contaminants diethylene and ethylene glycol.
It added that a sample of ‘Cold Out’ Syrup was obtained from Iraq and submitted for laboratory analysis. The sample was found to contain unacceptable amounts of diethylene glycol (0.25pc) and ethylene glycol (2.1pc) as contaminants.
The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10 per cent.
In the product alert, WHO said the manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.
“To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product,” the WHO said.
Previously, in September last year, the WHO said four products of Maiden Pharmaceuticals Limited (Haryana, India) were under scrutiny.
In December last year, the WHO raised an alert about two products of BIOTECH PVT. LTD, (Uttar Pradesh0.
This year, in April, a cough syrup manufactured by QP PHARMACHEM LTD (Punjab) was flagged by the WHO.
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