Recall of three Jean-Marie pharmaceutical products
25 Nov 2010
Jean-Marie Pharmacal Co Ltd (JM), a licensed drug manufacturer, in response to an order from Department of Health (DH) to recall from market a product which DH found to have a lower than the registered amount of an active ingredient, propantheline bromide, is also to recall two others which shared a same formulation voluntarily.
The drug found defective is Delna-U Tablet (HK-07441). JM is also recalling Elisa U Tablet (HK-07463) and Triganet Tablet (HK-28072) as a precautionary move with DH endorsement.
Samples of Delna-U Tablet collected during DH's market surveillance were found by the Government Laboratory to contain only 0.69mg of propantheline bromide per tablet, as against the registered content of 3mg per tablet.
A spokesman for DH said deviations from the registered amount of active ingredients of a pharmaceutical product could affect treatment effectiveness.
All three products involved are used for the treatment of stomach pain and gastric ulcers. They are pharmacy medicines and could only be sold under the supervision of a registered pharmacist in registered premises.
Based on information in hand, Delna-U Tablet was supplied to local pharmacies and some private doctors as well as to Macao, while Elisa U Tablet and Triganet Tablet were only for export to Macao.
The manufacturer has set up a hotline 2518 6517 for public enquiry between 9 am and 6 pm, Monday to Friday.
The spokesman urged healthcare professionals and retailers to stop supplying Delna-U Tablet to their clients. People who have used the affected product are advised to consult healthcare providers if in doubt.
The DH will closely monitor the recall while continuing with investigation.