Medicine recalls
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| Canada: Recall: Apo-Amitriptyline: Affected lots may exceed the interim acceptable intake limit for NNORT |
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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 or may exceed the interim acceptable intake limit for N-nitroso-nortriptyline (NNORT):
- Apo-Amitriptyline 10 mg Tablet (lot number: RN6384, RR0265, RR0266, RV1644, RV1645, RW8597, RW8598, TA6008, TA6009, TF8585, TF8586, TF8587, TF8588, TF8589, TW2842, TW2843)
- Apo-Amitriptyline 25 mg Tablet (lot number: RM0519, RM8130, RR0780, RR0781, RV1656, RV1657, RW8691, TA6061, TA6062, TF8602, TF8603)
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/apo-amitriptyline-affected-lots-may-exceed-interim-acceptable-intake-limit-nnort
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. The Department of Health (DH) has contacted Hind Wing to assess the local impact of the incident and Hind Wing will conduct recall on the affected lots of Apo-Amitriptyline Tab 10mg (HK-09273) and Apo-Amitriptyline Tab 25mg (HK-09274) from the market. A press statement will be issued.
Previously on 14 Aug 2023, the DH 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.
Related news was previously issued by Health Canada, Macao Pharmaceutical Administration Bureau and Health Sciences Authority, and was posted on the Drug Office website on 15 Aug 2023 and 17 Aug 2023.
Ends/Friday, Oct 18, 2024
Issued at HKT 19:15
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