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| Canada: Apotex recalls additional Apo-Acyclovir tablets due to a nitrosamine impurity (English only) |
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Health Canada announces that Apotex Inc. is recalling 4 additional lots of Apo-Acyclovir tablets, in 200 mg and 800 mg strengths, due to the presence of a nitrosamine impurity, N-nitrosodimethylamine (NDMA), above or close to the acceptable level. The affected products added are:
- Apo-Acyclovir 200 mg Tablet (lot number: RH9369, TF4466)
- Apo-Acyclovir 800 mg Tablet (lot number: TE5062, TH6119)
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/apotex-recalls-apo-acyclovir-tablets-due-nitrosamine-impurity
In Hong Kong, Apo-Acyclovir Tab 200mg (HK-43427) and Apo-Acyclovir Tab 800mg (HK-58228) are pharmaceutical products registered by Hind Wing Co Ltd (Hind Wing). Both products are prescription-only medicines.
On 29 Jul 2022, the Department of Health (DH) endorsed Hind Wing to recall a total of 3 batches of the following 2 products from the market:
- Apo-Acyclovir Tab 200mg (HK-43427) (batch number: TF4466)
- Apo-Acyclovir Tab 800mg (HK-58228) (batch number: TE5062, TH6119)
A recall statement was issued on the same date.
As confirmed with Hind Wing, Apo-Acyclovir Tab 200mg (batch number: RH9369) has not been imported into Hong Kong.
Previously on 28 Apr 2022, the DH endorsed Hind Wing to recall a total of 4 batches of the following 2 products from the market as a precautionary measure due to the presence of an impurity (NDMA) in the products:
- Apo-Acyclovir Tab 200mg (HK-43427) (batch number: RH9368, RH9370)
- Apo-Acyclovir Tab 800mg (HK-58228) (batch number: RP8516, RP8517)
A press statement was issued on the same date.
Related news was previously issued by Health Canada and Singapore Health Sciences Authority, and was posted on the Drug Office website on 29 Apr 2022.
Ends/Friday, Jul 29, 2022
Issued at HKT 18:00
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