The Department of Health (DH) today (June 26) endorsed a licensed drug wholesaler, Unam Corporation Ltd (Unam), to recall all batches of Enzyplex tablet (Hong Kong registration number: HK-06544) from the market due to a quality issue.
During the DH's investigation into a case of suspected mould contamination of the above product, samples of the product were collected from Unam, Hospital Authority (HA) as well as DH clinics for analysis to ascertain whether the product exceeds the pharmacopoeial standards on mould and yeast content.
Analysis on mould content of the samples, which usually require seven days, is still in progress. On the other hand, while the testing results revealed that the bacterial contents of the samples comply with pharmacopoeial requirements, the level exceeded the in-house specifications set by the Indonesia manufacturer of the product. Due to the quality issue, Unam recalls all batches of Enzyplex tablet from the market. The DH has also instructed Unam to ask the manufacturer in Indonesia to conduct an investigation and submit an investigation report as soon as possible.
Unam has set up a hotline (3665 2000) to answer public enquiries. So far, the DH has not received any adverse drug reaction reports in connection with the product.
Enzyplex tablet, containing vitamins and digestive enzymes, is an over-the-counter medicine for digestive disorders. According to Unam, about 128 000 bottles of 100 tablets and 46 000 bottles of 30 tablets of the product have been supplied to the HA, DH clinics, private hospitals, local private doctors, pharmacies and medicine stores, and also re-exported to Macao. The DH will closely monitor the recall.
People who have purchased the product should stop taking it. They should also seek advice from healthcare professionals if in doubt or feeling unwell after consumption.
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