Medicine recalls
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| Batch recall of Lynparza Capsules 50mg |
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The Department of Health (DH) today (February 21) endorsed a licensed drug wholesaler, AstraZeneca Hong Kong Limited (AstraZeneca), to recall 3 batches (Batch No.: NG699, NF848, NJ141) of Lynparza Capsules 50mg (registration number HK-64538) from the market due to potential quality issue.
The DH received notification from AstraZeneca that, during the ongoing stability testing of the above product, the manufacturer of the product in United States found that samples of the above batches may have a potential trend to exceed the limit set of the crystalline form of the active ingredient. Based on the preliminary investigation of the manufacturer, the issue is related to certain batches of active ingredient raw materials. Although the product passed all testing in the ongoing stability study, AstraZeneca recalls the affected batches as precautionary measure. The DH’s investigation is continuing.
The above product, containing olaparib, is a prescription medicine used for treatment of BRCA-mutated ovarian cancer.
According to AstraZeneca, 1,320 bottles containing 112 capsules per bottle of the affected batches have been supplied to Hospital Authority, private hospitals, private doctors and exported to Macao. The DH will closely monitor the recall.
So far, the DH has not received any adverse reaction reports in connection with the affected batches of product. |
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