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| Singapore: Recall of Amitriptyline Tablet 10mg (English only) |
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The Health Sciences Authority (HSA) announces that Pharmaforte Singapore Pte Ltd is recalling one batch of Apo-Amitriptyline Tablet 10mg (batch number: PY1904) to the retail level because the affected batch contains trace amounts of an impurity, N-nitrosodimethylamine (NDMA) above the acceptable level.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/product-recall/recall-of-amitriptyline-tablet-10mg
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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