Medicine recalls
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| Batch Recall of PMS-Duloxetine Delayed-Release Capsules 60mg |
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The Department of Health (DH) today (April 22) endorsed a licensed drug wholesaler, namely Trenton-Boma Limited (Trenton-Boma), to recall one batch (batch number: 640627) of PMS-Duloxetine Delayed-Release Capsules 60mg (HK-65447) from the market due to the presence of an impurity in the product.
The DH received notification from Trenton-Boma that the overseas manufacturer of the product is recalling the above batch due to the affected batch exceeded the interim acceptable limit for N-nitroso-duloxetine (NDLX). Some nitrosamine impurities are classified as probable or possible human carcinogen based on results from laboratory tests. As a precautionary measure, Trenton-Boma is voluntarily recalling the above batch from the market.
The above product, containing duloxetine, is a prescription medicine used for the treatment of depression. According to Trenton-Boma, the product has been imported into Hong Kong and supplied to the private doctors, veterinary surgeon and pharmacies.
Trenton-Boma has set up a hotline (2370 2092) to answer related enquiries.
So far, the DH has not received any adverse reaction reports in connection with the above batch of product. The DH will closely monitor the recall.
Patients who are taking the above product should not stop taking the medicine, but should consult their healthcare professionals as soon as possible for appropriate arrangements.
Ends/Monday, April 22, 2024
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