Medicine recalls
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| Singapore: Recall of Apo-Amitriptyline 10 Tablet |
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Health Sciences Authority (HSA) announces that Pharmaforte Singapore Pte Ltd is recalling one batch of Apo-Amitriptyline 10mg Tablet (batch number: RM0518) to the retail level due to an impurity, N-nitroso-nortriptyline (NNORT), was found to be above the acceptable level in one batch of Apo-Amitriptyline 10mg Tablet. As a precautionary measure, the affected batch is recalled.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/product-recall/recall-of-apo-amitriptyline-10mg-tablet
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 (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 and Macao Pharmaceutical Administration Bureau, and was posted on the Drug Office website on 15 Aug 2023.
Ends/Thursday, Aug 17, 2023
Issued at HKT 16:00
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