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Products found to contain undeclared medicines

Public urged not to buy or use Steelman Capsules 2 with undeclared and controlled ingredient (with photo)
The Department of Health (DH) today (April 11) urged the public not to buy or use a product called "Steelman Capsules 2" as it was found to contain an undeclared and controlled ingredient.

During DH’s market surveillance exercise, samples of "Steelman Capsules 2" were purchased for analysis by the Government Laboratory. Today, test results showed that the product contains aminotadalafil, an analogue of a virility drug ingredient tadalafil. The product is not a registered pharmaceutical product in Hong Kong.

The product’s distributor, Top Harvest Pharmaceuticals Company Limited (Top Harvest), was raided today and 439 boxes of Steelman Capsules 2 were seized. According to Top Harvest, the product was imported from the United States into Hong Kong and about 19,500 boxes have been supplied to local dispensaries and medicine companies since 2012.

Top Harvest was instructed to recall all Steelman Capsules 2 from the market. The company has set up a hotline (2668 4802) to answer public enquiries. The DH will closely monitor the recall.

DH’s investigation is continuing.

Tadalafil is a Part I poison under the Pharmacy and Poisons Ordinance (Cap 138) (the Ordinance). It is a virility drug which should only be used under the advice of a doctor. The product can only be supplied at pharmacies under the supervision of a registered pharmacist and upon a doctor’s prescription. The side effects of tadalafil include low blood pressure, headache, vomiting, dizziness and transient vision disturbances. It may interact with some drugs (such as nitroglycerin for treatment of angina) and cause decrease in blood pressure to dangerous levels. Improper use of tadalafil may pose serious health risks, especially for patients with heart problems. Aminotadalafil, being chemically similar to tadalafil, is expected to pose similar health risks. Aminotadalafil is also a Part I poison under the Ordinance.

According to the Ordinance, all pharmaceutical products must be registered with the Pharmacy and Poisons Board of Hong Kong (the Board) before they can be sold legally in the market. Illegal sale and possession of unregistered pharmaceutical products or Part I poisons are criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years’ imprisonment.

A DH spokesperson strongly urged members of the public not to buy or use products of doubtful composition or unregistered pharmaceutical products as such products have not been evaluated by the Board and their safety, quality and efficacy may not be guaranteed. All registered pharmaceutical products should carry a Hong Kong registration number on the package in the format of “HK-XXXXX”.

Members of the public who have purchased the above product should stop taking it immediately and consult healthcare professionals for advice if they are in doubt or feeling unwell after using it. They may submit the product to the DH’s Drug Office at Room 1856, Wu Chung House, 213 Queen’s Road East, Wan Chai, during office hours for disposal.