药 物 回 收
|
| |
| Canada: Recall: Apo-Acyclovir Tablets: NDMA impurity (English only) |
| |
Health Canada announces that Apotex Inc. is recalling the following products from wholesalers, retailers and healthcare establishments because the affected lots exceed concentration limit for N-nitrosodimethylamine (NDMA):
- Apo-Acyclovir 200mg Tablet (lot number: TE5048, TK5832)
- Apo-Acyclovir 400mg Tablet (lot number: TH6095, TH6096, TH6098)
- Apo-Acyclovir 800mg Tablet (lot number: TK1734, TK3921)
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/apo-acyclovir-tablets-ndma-impurity
In Hong Kong, Apo-Acyclovir Tab 200mg (HK-43427), 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 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, the other four lots of the products recalled in Canada have 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 2 Aug 2022.
Ends/Tuesday, Aug 15, 2023
Issued at HKT 15:30
|
| |
|
