Health product recall

Apo-Acyclovir Tablets: NDMA impurity

Last updated

Summary

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

See instructions below. 

Affected products

Brand

Product Name

Market Authorization

Dosage Form

Strength

Lot

Apotex

Apo-Acyclovir 200mg

DIN 02207621

Tablet

Acyclovir 200mg

RH9370, RH9368

Apotex

Apo-Acyclovir 800mg

DIN 02207656

Tablet

Acyclovir 800mg

RT8943, RP8516, RP8517

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: 2022-04-28
Alert / recall type
Health product recall
Category
Health product - 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