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| Canada: Recall: APO-AMITRIPTYLINE Tablet 10mg: NDMA Impurity (English only) |
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Health Canada announces that Apotex Inc. is recalling one lot of APO-AMITRIPTYLINE Tablet 10mg (lot number: PY1904) from retailers, wholesalers and healthcare establishments because the affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 48-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-0
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.
On 3 Feb 2023, the Department of Health endorsed Hind Wing to recall one batch of Apo-Amitriptyline Tab 10mg (HK-09273) (batch number: PY1904) due to the presence of impurity in the product. A recall statement was posted on the Drug Office website on the same date.
Related news on the presence of impurity in the above product was previously issued by various drug regulatory authorities, and was posted on the Drug Office website since 15 Apr 2021, with the latest update posted on 6 Feb 2023.
Ends/Wednesday, Feb 8, 2023
Issued at HKT 15:00
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