Medicine recalls
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| Singapore: Recall of Apo-Amitriptyline 10mg & 25mg Tablets |
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The Health Sciences Authority (HSA) announces that Pharmaforte Singapore Pte Ltd is recalling Apo-Amitriptyline 10 mg Tablet (batch number: RR0266, RV1644, RV1645, RW8598, TA6008, TF8585, TF8588, TF8589) and Apo-Amitriptyline 25 mg Tablet (batch number: TA6062, TF8602, TF8603) to the retail level because one batch (TF8589) was found to contain the presence of an impurity, N-nitroso-nortriptyline (NNORT), above the acceptable level. The additional batches are recalled as a precautionary measure.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/product-recall/recall-of-apo-amitriptyline-10mg-and-25mg-tablets
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 18 Oct 2024, the Department of Health (DH) endorsed Hind Wing to recall a total of 14 batches of Apo-Amitriptyline Tab 10mg (HK-09273) (batch number: RN6384, RR0266, RV1644, RW8597, TA6008, TF8585, TF8587, TF8589) and Apo-Amitriptyline Tab 25mg (HK-09274) (batch number: RM8130, RR0781, RV1656, RW8691, TA6062, TF8602) from the market as a precautionary measure due to the presence of impurity (NNORT) in the products. A press statement was posted on the Drug Office website on the same date.
Previously on 14 Aug 2023, the DH endorsed Hind Wing to recall one batch of Apo-Amitriptyline Tab 10mg (HK-09273) (batch 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 since 15 Aug 2023, with the latest update posted on 19 Oct 2024.
Ends/Saturday, Oct 26, 2024
Issued at HKT 12:00
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