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| Singapore: Recall of Apo-Acyclovir Tablet 400mg and Apo-Acyclovir Tablet 800mg (English only) |
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Health Sciences Authority (HSA) announces that Pharmaforte Singapore Pte Ltd is recalling two batches of Apo-Acyclovir tablet 400mg (batch number: TH6096 and TH6098) and one batch of Apo-Acyclovir Tablet 800mg (batch number: TK1734) to the retail level due to an impurity, N-nitrosodimethylamine (NDMA), was found to be above the acceptable level in three batches of Apo-Acyclovir Tablets. As a precautionary measure, the affected batches are recalled.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/product-recall/recall-of-apo-acyclovir-tablet-400mg-and-apo-acyclovir-tablet-800mg
In Hong Kong, Apo-Acyclovir Tab 400mg (HK-58229) and Apo-Acyclovir Tab 800mg (HK-58228) are pharmaceutical products registered by Hind Wing Co Ltd (Hind Wing). All products are prescription-only medicines.
On 14 Aug 2023, the Department of Health (DH) endorsed Hind Wing to recall a total of three lots of the three products from the market as a precautionary measure due to the presence of impurity (NDMA) in the products:
- Apo-Acyclovir Tab 200mg (HK-43427) (lot number: TK5832)
- Apo-Acyclovir Tab 400mg (HK-58229) (lot number: TH6096)
- Apo-Acyclovir Tab 800mg (HK-58228) (lot number: TK1734)
A press statement was posted on the Drug Office website on the same date.
As confirmed with Hind Wing, Apo-Acyclovir tablet 400mg (batch number: TH6098) that was recalled in Singapore has not been imported into Hong Kong.
Related news was previously issued by Health Canada and Singapore Health Sciences Authority, and was posted on the Drug Office website since 29 Apr 2022, with the latest update posted on 15 Aug 2023.
Ends/Thursday, Aug 17, 2023
Issued at HKT 16:00
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