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The Department of Health (DH) today (February 19) endorsed a licensed drug wholesaler, Hind Wing Co Ltd, to conduct a voluntary recall of one batch (batch number: KJ3194) of Apo-Naproxen Tablet 250mg (registration number: HK-34921) from the market due to a potential quality issue.
The DH today received notification from Hind Wing that the product's manufacturer in Canada, Apotex Inc, had found some batches of the product may contain foreign material embedded in tablets and the foreign material originated from silicon tubing in contact with the tablets during the manufacturing process. Inadvertent ingestion of small particles of silicon is not expected to cause serious systemic effects. However, there is a potential risk of mechanical irritation or trauma to the upper gastrointestinal tract. Apotex Inc initiated this voluntary recall in co-ordination with the health authority of Canada. The DH has requested Apotex Inc to provide a detailed investigation report as soon as possible.
Apo-Naproxen Tablet 250mg, containing naproxen, is a prescription medicine used for relief of inflammation and pain. It can only be supplied by pharmacies under the supervision of a registered pharmacist upon doctors' prescription.
According to Hind Wing, only one of the affected batches (batch number: KJ3194), with 198 bottles (1,000 tablets each) in total, had ever been imported to Hong Kong since March 2013. Among the imported stock, 188 bottles were supplied to DH clinics, a private hospital, local private doctors and pharmacies while the rest were exported to Macau. The DH has already informed the relevant authority of Macau on details of the recall.
So far, the DH has not received any adverse reaction report related to the use of the product. The DH's investigation is continuing.
Hind Wing has set up a hotline (2566 0562) to answer related enquiries. The DH will closely monitor the recall.
"Health-care providers should stop supplying the affected product to their clients. Members of the public who are consuming the product should consult their health-care professionals if in doubt," a DH spokesman said.
Ends/Wednesday, February 19, 2014
Issued at HKT 19:45
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