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The Department of Health (DH) today (June 20) endorsed the voluntary recall of two registered pharmaceutical products by the holder of certificates of drug/product registration, Mannings, from the market and consumers due to presence of plasticisers detected in the products during an in-house chemical analysis.
DH received notification from Manning's mother company, The Dairy Farm Company Limited (Dairy Farm), today that Mannings Sore Throat Lozenges 0.25mg (Registration No.: HK-60010) and Mannings Folic Acid 5mg (Registration No.: HK-59704) were found to contain Di (2-ethylhexyl) phthalate (DEHP) and Diisononyl phthalate (DINP) during the company's testing of its locally registered products. Mannings Sore Throat Lozenges 0.25mg was found to contain DEHP at a level of 1.4ppm and DINP at a level of 3.8ppm while Mannings Folic Acid 5mg was found to carry DEHP at a level of 1.3ppm and DINP at 1.6ppm.
Mannings Sore Throat Lozenges 0.25mg is used for soothing sore throat whereas Mannings Folic Acid 5mg is a dietary supplement. The two products are manufactured in Singapore and imported by Dairy Farm for local sale in Mannings' shops.
A spokesman for DH said that safety concern about DEHP and DINP is on chronic toxicity after long-term consumption because it may affect liver and kidney. Moreover, it may also be associated with the risk of cancer although this relation with DINP is not well documented.
"According to the Public Health and Municipal Services Ordinance (Cap. 132), selling of a drug not of the nature, substance or quality demanded by the purchaser is an offence. The maximum penalty involved is a fine of $10,000 and three months' imprisonment. DH will refer the whole matter for the Department of Justice's legal advice on completion of investigation," the spokesman added.
After receiving notification, DH has already obtained samples of the two concerned products for Government Laboratory's further analysis.
DH has also informed regulatory authority of Singapore about the recall exercise in Hong Kong for their necessary follow-up.
Mannings has set up a hotline, 2299 3381, for enquiries during office hours. So far, no adverse event reports have been received.
The spokesman advised members of the public to stop using the above products immediately. "Anyone who has used the products and was either in doubt or feeling unwell should seek professional advice from healthcare providers," he said.
"The DH will continue to keep a close watch on the plasticiser incident, monitor the present incident and keep track of the recall exercise besides maintaining enhanced vigilance on pharmaceutical products."
Ends/Monday, June 20, 2011
Issued at HKT 22:28
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