Medicine recalls
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| Canada: Recall: Apo-Amitriptyline Tablets: NNORT impurity |
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Health Canada announces that Apotex Inc. is recalling the following products from wholesalers, retailers and healthcare establishments because the affected lots exceed interim acceptable intake limit of 2.5 ppm for nitrosamine impurity N-nitroso-nortriptyline (NNORT):
- Apo-Amitriptyline 10mg Tablet (lot number: PY1833, RM0518)
- Apo-Amitriptyline 25mg Tablet (lot number: PV0569)
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/apo-amitriptyline-tablets-nnort-impurity
In Hong Kong, Apo-Amitriptyline Tab 10mg (HK-09273) and Apo-Amitriptyline Tab 25mg (HK-09274) are pharmaceutical products registered by Hind Wing Co Ltd (Hind Wing). Both products are prescription-only medicines.
On 14 Aug 2023, the Department of Health endorsed Hind Wing to recall one lot of Apo-Amitriptyline Tab 10mg (HK-09273) (lot number: RM0518) from the market as a precautionary measure due to the presence of impurity (NNORT) in the product. A press statement was posted on the Drug Office website on the same date.
As confirmed with Hind Wing, the other two lots of the products recalled in Canada have not been imported into Hong Kong.
Ends/Tuesday, Aug 15, 2023
Issued at HKT 15:30
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