The Department of Health (DH) today (May 7) directed licensed drug manufacturer Quality Pharmaceutical Laboratory Ltd to recall all its products from the market in view of further quality defects on analysis of its products.
The manufacturer has registered a total of 434 products in Hong Kong. A list of the products can be found in the Annex.
Since the incident of the first recall on April 20, the manufacturer has suspended its distribution to facilitate the DHs investigation. As part of the investigation, some 90 products have been sampled for laboratory analysis.
With the testing almost near completion, a total of 13 products with defects have been found so far. Nine products had failed the disintegration time test resulting in two recalls on April 20 and 26 respectively. Today, four other products were found to contain lower than registered content of their active ingredients.
The quality defects reflected that there were likely to be deficiencies during the manufacturing processes. As a result, the DH directed the manufacturer to recall all its products.
The manufacturer is required to conduct a full review of its quality system and to institute remedial measures to the satisfaction of the DH.
The four products found failed today were Quali-mentin 625mg Tablet (Registration No. HK-53630), Quali-mentin 1g Tablet (Registration No. HK-53631), Vitamin B2 10mg Tablet (Registration No. HK-27448) and Digezym Tablet (Registration No. HK-35761).
Quali-mentin 625mg Tablet and Quali-mentin 1g Tablet are antibiotics used as antibacterial agents. They can only be sold in dispensaries on a doctors prescription and under the supervision of a pharmacist. Vitamin B2 10mg Tablet and vitamin-contained Digezym Tablet are over-the-counter medicines.
A DH spokesman said that although all the above laboratory findings pointed to quality defects, there could be therapeutic consequences.
The manufacturer has set up a hotline, 2429 8412, for public enquiries. The DH will closely monitor the recall.
The DH spokesman urged healthcare professionals and retailers to stop supplying the products manufactured by the manufacturer to their clients. People who have used the products should consult their healthcare professionals if in doubt, he said.