The Department of Health (DH) today (April 7) instructed Main Life Corporation Ltd (Main Life), a licensed pharmaceutical wholesaler, to recall from the market five pharmaceutical products with un-registered sales packs, two of which also carry un-registered medical indications.
A DH spokesman said the five products with un-registered sales packs were Dexaltin Oral Paste 50 x 2g tubes per pack; Dopareel 7.5 mg 500 tablets in blister per pack; Dopareel 10 mg 500 tablets in blister per pack, Glutathion 40 tablets per pack and 100 tablets per pack; and Lacspan powder 12 sachets per pack.
Glutathion 40 tablets per pack and 100 tablets per pack as well as Lacspan powder 12 sachets per pack were also found to carry un-registered medical indications.
Dexaltin Oral Paste is used to treat mouth ulcers. Dopareel 7.5 mg and 10 mg tablets are both sleeping tablets. Glutathion tablets are used as antioxidants while Lacspan Powder is used to restore gut flora.
He said DH inspected the office of Main Life following a media enquiry about malpractice of the company yesterday and detected the irregularities.
The products were sold to private hospitals, private doctors, pharmacies and medicine shops.
The spokesman said under the Pharmacy and Poisons Ordinance, a pharmaceutical product was regarded as registration drug only if the particulars of the product, including its pack size and package information, corresponded exactly with its registered particulars.
Any change of the registrable particulars must be approved by the Pharmacy and Poisons Board, he said.
The spokesman said based on available information, there was no immediate safety, efficacy or quality concern with the use of three of the products, namely Dexaltin oral paste, Dopareel 7.5 mg tablet and Dopareel 10 mg tablet.
As for Glutathion 40 tablets per pack and 100 tablets per pack; and Lacspan powder 12 sachets per pack, there were no evidence to support the un-registered medical indications.
However, doctors and pharmacists are reminded to stop administering the five products to their clients as the products are un-registered in Hong Kong.
DH has instructed the company to recall the products from the market.
The company has set up a hotline (2524 2462) to answer clients' enquiries.
DH has also set up a hotline (2319 2905) for enquiries. The hotline will operate from 9am to 5pm on weekdays.
DH's investigation is ongoing.
The spokesman said sale of unregistered pharmaceutical product was an offence under the Pharmacy and Poison Ordinance. Upon conviction, the maximum penalty is a fine of HK$100,000 and two years' imprisonment.
Reprinted from HKSAR Government web page:
http://www.info.gov.hk/gia/general/200904/07/P200904070264.htm