Health product recall

Apo-Acyclovir Tablets: NDMA impurity (Updated with new product and lot numbers)

Last updated

Summary

Product
Apo-Acyclovir Tablets
Issue
Health products - Contamination
What to do

Continue taking your medication unless you have been advised to stop by your health care provider. You do not need to return your medication to your pharmacy. Not treating your condition may pose a greater health risk.

Affected products

Brand Product Name Market Authorization Dosage Form Strength Lot
Apotex Apo-Acyclovir 200mg DIN 02207621 Tablet Acyclovir 200mg RH9370, RH9368, RH9369, TF4466 New Lots: TE5048, TK5832
Apotex New Product: Apo-Acyclovir 400mg DIN 02207648 Tablet Acyclovir 400mg New Lots: TH6095, TH6096, TH6098
Apotex Apo-Acyclovir 800mg DIN 02207656 Tablet Acyclovir 800mg RT8943, RP8516, RP8517, TE5062, TH6119 New Lots: TK1734, TK3921

Issue

Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA).

What you should do

  • Continue taking your medication unless you have been advised to stop by your health care provider. You do not need to return your medication to your pharmacy. Not treating your condition may pose a greater health risk.
  • Talk to your health care provider if you are taking a recalled product and are concerned about your health.
  • If you have questions about the recall, contact Apotex Inc. at 1-888-628-0732 or by email at apotex4315@sedgwick.com.
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Previous recalls or alerts
Background

Depth of recall: Retailers, Wholesalers, Healthcare establishments. 

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

Apotex Inc.

150 Signet Drive,

Toronto, Ontario,

M9L 1T9

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-64118
History
Change log
2022-07-28: New lot numbers added
2023-08-14: New product and lot numbers added

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