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Apotex Inc.
  150 Signet Drive,
North York,
ON, M9L 1T9
Canada

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News

Aug 9, 2023
Voluntary Recall of seven (7) lots of APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard)

Public Communication

Important Safety Information on APO-ACYCLOVIR

(Acyclovir Tablets Apotex Standard)

Date: 08/09/2023
Voluntary Recall of seven (7) lots of APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard).

Apotex has initiated a voluntary Type I recall to the Pharmacy Level for seven (7) lots of “APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard)” as identified below. This recall is being initiated due to five (5) lots in which the acceptable intake limit for N-nitrosodimethylamine (NDMA), as established by Health Canada, has been exceeded. Out of an abundance of caution, the company extends the recall to include two (2) additional lots as identified below. To date, there are no relevant adverse event reports or complaints received for any of these seven (7) lots. The details for the lots being recalled are listed below:

PRODUCT

DIN

UPC

STRENGTH

SIZE / FORMAT

LOT

EXP. DATE (mm/yyyy)

APO-ACYCLOVIR

(Acyclovir Tablets Apotex Standard)

02207621

771313080316

200 mg

100 BTL

TE5048

06/2024

02207621

771313080316

200 mg

100 BTL

TK5832

05/2025

02207648

771313080330

400 mg

100 BTL

TH6096

12/2023

02207648

771313080330

400 mg

100 BTL

TH6095

12/2023

02207648

771313080330

400 mg

100 BTL

TH6098

12/2023

02207656

771313080347

800 mg

100 BTL

TK1734

05/2024

02207656

771313080347

800 mg

100 BTL

TK3921

05/2024

 

APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard) is indicated for the treatment of initial episodes of herpes genitalis, for the suppression of unusually frequent recurrences of herpes genitalis (6 or more episodes per year) and for acute treatment of herpes zoster (shingles).

To report a suspected adverse reaction associated with the use of APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard) patients may contact Apotex by calling 1-800-667-4708 or 416-401-7780 (follow prompts), by email at drug.safety@apotex.com or by fax at 1-866-429-9133 or 416-401-3819.

Patients may also report any suspected adverse reactions associated with the use of health products to Health Canada by calling toll free at 1-866-234-2345 or by visiting MedEffect Canada's Web page on Adverse Reaction Reporting https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax.