Batch recall of Colchicine Tablets 0.5mg

10 September 2019
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The Department of Health (DH) today (September 10) endorsed a licensed drug wholesaler, Welldone Pharmaceuticals Limited (Welldone), to recall one batch (batch number: CCE802) of Colchicine Tablets 0.5mg (both packs of 100 tablets and 1000 tablets) (Hong Kong registration number: HK-60077) from the market due to a potential quality issue.

The DH received notification from Welldone today that one of the manufacturing processes of the affected batch manufactured in Taiwan was found not to be in compliance with the Good Manufacturing Practice requirements. Even though the finished product complied with the specifications, the manufacturer is recalling the affected batch as a precautionary measure.

The above product, containing Colchicine, is a prescription medicine used for the treatment of gout. According to Welldone, the affected batch of product has been supplied to local private doctors and pharmacies. Some products were also re-exported to Macao.

Welldone has set up a hotline (2467 1168) to answer related enquiries.

"So far, the DH has not received any adverse reaction report in connection with the product. The DH will closely monitor the recall," a spokesman for the DH said.

"Members of the public should consult healthcare professionals if in doubt or feeling unwell after using the product," the spokesman added.

Reposted from HKSAR Government webpage:
https://www.info.gov.hk/gia/general/201909/10/P2019091000749.htm