Medicine recalls
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| Batch Recall of Cinacalcet Tablets 30 mg |
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The Department of Health (DH) today (April 10) endorsed a licensed drug wholesaler, namely Controlled Medications Limited (CML), to recall a total of two batches (batch number: 4PB0528 and 5PB0173) of the pharmaceutical product, namely Cinacalcet Tablets 30 mg from the market as a precautionary measure due to potential quality issues.
The DH received notification from CML that the overseas manufacturer of the concerned product is recalling the above batches of Cinacalcet Tablets 30 mg as they exceed the accepted level of an impurity, n-nitroso-cinacalcet. N-nitroso-cinacalcet is classified as a probable human carcinogen based on results from laboratory tests. As a precautionary measure, CML voluntarily recalls the affected batches from the market.
The above product, containing cinacalcet, is a prescription only medicine indicated for the treatment of certain parathyroid conditions. The product is not registered in Hong Kong but was imported for the treatment of particular patients by the Hospital Authority (HA). According to CML, the affect batches were imported into Hong Kong and supplied solely to the HA.
CML has set up a hotline (2896 0889) to answer related enquiries.
So far, the DH has not received any adverse reaction reports in connection with the above product. The DH will closely monitor the recall.
Patients who are taking the above batches of product should not stop taking the medicine, but should consult their healthcare professionals as soon as possible for appropriate arrangements.
Ends/ Friday, 10 April 2026 |
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