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