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| Canada: Recall: APO-AMITRIPTYLINE 10mg Tablet: NDMA impurity (English only) |
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Health Canada announces that Apotex Inc. is recalling one lot of APO-AMITRIPTYLINE 10mg Tablet (lot number: PY1832) from wholesalers, retailers and healthcare establishments because the affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 36-month stability testing timepoint.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/apo-amitriptyline-10mg-ndma-impurity
In Hong Kong, Apo-Amitriptyline Tab 10mg (HK-09273) is a pharmaceutical product registered by Hind Wing Co Ltd (Hind Wing). The product is a prescription-only medicine. As confirmed with Hind Wing, the above affected lot 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. Related news was previously issued by Health Canada and Macau Health Bureau, and was posted on the Drug Office website on 15 Apr 2021, 16 Apr 2021 and 3 May 2021.
Ends/Thursday, Jan 27, 2022
Issued at HKT 16:00
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