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Jordan Berman
Vice President,
Global Corporate Communications

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

  416-401-7487
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Press Center

Jul 27, 2022
Voluntary Recall of four (4) lots of APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard) 200 mg and 800 mg

Public Communication

Important Safety Information on APO-ACYCLOVIR

(Acyclovir Tablets Apotex Standard) 200 mg and 800 mg

Date: 04/27/2022
Voluntary Recall of four (4) lots of APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard) 200 mg and 800 mg.

Apotex has initiated a voluntary Type I recall to the Pharmacy Level for four (4) lots of “APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard)”. This recall is being initiated due to three lots (RH9369, TE5062 & TH6119) 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 one (1) additional one lot (TF4466). NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. 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

RH9369

TF4466

08/2022

08/2024

02207656

771313080347

800 mg

100 BTL

TE5062

TH6119

06/2023

12/2023

 

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.