KUALA LUMPUR: The Health Ministry’s Pharmaceutical Services Division has ordered Royce Pharma Sdn Bhd to recall its Paracetamol 120mg/5ml syrup from the local market and health facilities concerned as it contained alcohol.
Its senior director, Datuk Eisah A Rahman, said the company had failed to declare the alcohol content on the label and packaging of the product.
“The ministry had granted offer to the company to supply the product as it did not mention the alcohol content in either the label or the leaflet of the product,” she said in a statement here yesterday.
However, Eisah said the product had been registered with the ministry’s Drug Control Authority (PBKD) and adhered to the quality, safety and effectiveness standard.
“Members of the public need not worry as the product contained alcohol within permissible level and poses no safety issue,” she said.
She also advised consumers to always read and check the content label and leaflet of a product and only choose the appropriate product needed.
Consumers can contact the ministry’s Pharmaceutical Services Division at 1 800 886 772 or email [email protected] for further information about medicines.
Meanwhile, Royce Pharma Sdn Bhd deputy chairman Datuk Chandrasekar Suppiah said the company would recall the product following the Health Ministry’s directive to set new specifications regarding alcohol content.
“The product had initially adhered to the quality, safety and effectiveness standard set but now the ministry wants the product be produced without ethanol (alcohol) content, and we will produce a new product without alcohol after this,” he told Bernama.
Chandrasekar said members of the public need not worry as no safety issues were reported on the product since it was manufactured and marketed beginning 1991 and it contained ethanol within the permissible level.
“The product is safe and complied with the ministry’s Drug Control Authority (PBKD) standard and the company has always been committed to produce safe pharmaceutical products,” he said.
He said Royce Pharma Sdn Bhd was also recognised as the only company that adhered to Syariah (MS1900: 2008) requirements. — Bernama