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The Department of Health (DH) today (December 17) instructed a licensed drug wholesaler, Today Pharma Company Limited (Today Pharma), to recall a batch of Dexasan-C Eye Drops (Dexasan-C) (registration number: HK-59504, batch number: AS033) from the market due to a quality issue.
Under the DH's market surveillance, samples of the above batch of Dexasan-C were taken for analysis. Upon the Government Laboratory's testing, the content of one of the active ingredients, chloramphenicol, was found to be lower than the labelled amount. The quality defect may affect the efficacy of the product. As a precautionary measure, the DH instructed Today Pharma to recall the above batch from the market.
The root cause of the issue is still under investigation. The DH has requested the product's manufacturer in India, SRS Pharmaceuticals Pvt Ltd, to provide a detailed investigation report as soon as possible.
"Dexasan-C, containing drug ingredients chloramphenicol and dexamethasone, is a prescription medicine used for the treatment of eye infections and inflammation. It can only be supplied by pharmacies under the supervision of a registered pharmacist upon doctors' prescription," a spokesman for the DH explained.
According to Today Pharma, 20,600 bottles of the affected batch of eye drops were imported to Hong Kong in April 2012. About 16,800 bottles have been sold to local private doctors and pharmacies while 1,100 bottles were exported to Macao. The affected batch is the only batch in the local market and it will expire by January 2014.
"The DH's investigation is proceeding and we will closely monitor the recall. We have informed the drug regulatory authority of Macao accordingly," the spokesman added.
No adverse reports in connection with the product have been received by the DH so far.
Today Pharma has set up a hotline (2677 2098) for related enquiries.
"Healthcare providers should stop supplying the affected products to their clients. Members of the public who are using the product should consult their healthcare professionals if in doubt or when symptoms persist," the spokesman urged.
Ends/Tuesday, December 17, 2013
Issued at HKT 18:49
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