Medicine recalls
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| Batch recall of Regpara Tablets 25mg due to presence of impurity |
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The Department of Health (DH) today (12 February) endorsed a licensed drug wholesaler, DKSH Hong Kong Limited (DKSH), to recall a total of 10 batches (batch number: DES169675, DHS171505, DMS173037, DBS176064, DBS176065, EES176886, EES177675, EHS178805, EHS179575 and ENS181132) of Regpara Tablets 25mg (Hong Kong registration number: HK-58066) from the market as a precautionary measure due to the presence of impurity in the product.
The DH received notification from DKSH that the overseas manufacturer of the product is recalling the above batches of Regpara Tablets 25mg as they may exceed the acceptable daily intake limit 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, DKSH is voluntarily recalling the affected batches of product from the market.
The above product, containing cinacalcet, is a prescription medicine primarily used for the treatment of secondary hyperparathyroidism in patients undergoing maintenance dialysis. According to DKSH, the affected batches of product have been imported into Hong Kong and supplied to the Hospital Authority, local private hospitals, private doctors and pharmacies, and re-exported to Macao.
DKSH has set up a hotline (2963 6892) to answer related enquiries.
So far, the DH has not received any adverse reaction reports in connection with the 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/Wednesday, Feb 12, 2025
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