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The Department of Health (DH) has instructed licensed drug manufacturer Quality Pharmaceutical Laboratory Ltd to recall all batches of Mefenamic Acid 500mg and Mefenamic Acid 250mg tablets from the retail level today (April 20) as both drugs failed the disintegration time test.
The testing was performed consequent to Macao authority's announcement last night that the said company had to recall one batch (Batch No. 80801) of its Mefenamic Acid 500mg tablet, a preparation which is destined for Macao's market and is not available in Hong Kong, because of failed disintegration time test detected through surveillance. Laboratory analysis by Hong Kong's Government Laboratory today confirmed Macao authority's finding.
Moreover, testing on samples of another Mefenamic Acid 500mg tablet and 250mg tablet, both of which are registered for sale in Hong Kong, with registration number HK-35728 and HK-45417 respectively, also indicated failure in their disintegration time. The latter is a quality defect, but could have therapeutic bearing.
It is known that the products have been sold to private doctors and pharmacies.
In Hong Kong, Mefenamic Acid is a prescription drug used for relieving pain. It can only be sold in dispensaries on a doctor's prescription and under the supervision of a pharmacist.
Quality Pharmaceutical Laboratory Ltd. has voluntarily suspended all drug distribution to facilitate DH's investigation. A hotline (2429 8412) has also been set up to handle public enquiries. DH will closely monitor the recall.
A DH spokesman reminded healthcare professionals and retailers to stop supplying the concerned products to their clients.
People who have used the products should consult their healthcare professionals if in doubt.
Ends/Tuesday, April 20, 2010
Issued at HKT 19:41
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