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

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News

Apr 26, 2022
Voluntary Recall of five (5) 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: 04/26/2022
Voluntary Recall of five (5) 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 five (5) lots of “APO-ACYCLOVIR (Acyclovir Tablets Apotex Standard)”. This recall is being initiated due to these lots in which the acceptable intake limit for N-nitrosodimethylamine (NDMA), as established by Health Canada, has been exceeded. 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

RH9368

RH9370

08/2022

08/2022

02207656

771313080347

800 mg

100 BTL

RP8516

RP8517

RT8943

07/2022

07/2022

07/2022

 

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.