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| Canada: Recall: APO-AMITRIPTYLINE 10mg Tablet: Update (English only) |
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Health Canada announces that Apotex Inc. is recalling a second lot of APO-AMITRIPTYLINE 10mg Tablet (lot number: PY1831) from retailers, wholesalers and healthcare establishments due to presence of higher than accepted levels of a nitrosamine impurity known as N-nitrosodimethylamine (NDMA) in the affected lot.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../75519r-eng.php
In Hong Kong, Apo-Amitriptyline Tab 10mg (HK-09273) is a pharmaceutical product registered by Hind Wing Co Ltd (Hind Wing), and is a prescription-only medicine. As confirmed with Hind Wing, the affected lot (lot number: PY1831) has not been imported into Hong Kong.
On 15 Apr 2021, the Department of Health (DH) endorsed Hind Wing to recall one lot of Apo-Amitriptyline Tab 10mg (HK-09273) (lot number: RF0410) from the market as a precautionary measure due to the presence of an impurity in the product. A press statement was issued on the same date. The DH will continue to monitor the recall. Related news was previously issued by Health Canada and Macau Health Bureau, and was posted on the Drug Office website on 15 Apr 2021 and 16 Apr 2021.
Ends/Monday, May 3, 2021
Issued at HKT 15:00
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